Priority New Monograph Items

USP is seeking monographs for the following drug substances and drug products that are or soon will be off patent and thus are of the highest priority. USP also is seeking monographs for the excipients listed below. Monographs are marked received upon receipt of monograph proposal. Received monographs are removed from this list upon publication in Pharmacopeial Forum or when posted in the Pending Monographs section of the USP Web site (http://www.usp.org/standards/pending/). (This list has been updated as of April 22, 2008.) The next update of this list will be approximately June 25, 2008.

Monograph sponsors should consult USP's Guideline for Submitting Requests for Revision to the USP–NF.

For additional information, contact Karen A. Russo, Ph.D., .

Small Molecules Actives (Drug Substances) | Small Molecules Actives (Drug Products) | Excipients

MONOGRAPH NAME

Small Molecules Actives (Drug Substances)

1. Allopurinol Sodium 2. Aminopropazine Fumarate 3. Aminopterin Sodium
4. Anagrelide Hydrochloride – RECEIVED 5. Arsenic Trioxide 6. Auranfoin
7. Azelaic Acid – RECEIVED 8. Balsalazide Disodium 9. Bentoquatam
10. Benzphetamine Hydrochloride 11. Bivalirudin – RECEIVED 12. Calcipotriene
13. Calcium Trisodium Pentetate 14. Calfactant 15. Candesartan Cilexetil – RECEIVED
16. Carmustine – RECEIVED 17. Cefditoren Pivoxil – RECEIVED 18. Ceftibuten
19. Cetrorelix 20. Cevimeline 21. Chloroxine
22. Choline Salicylate 23. Cysteamine Bitartrate 24. Cytarabine Liposome
25. Dalfopristin 26. Dapirazole Hydrochloride 27. Desirudin
28. Desonide – RECEIVED 29. Dexrazoxane 30. Dextromethorphan Polistirex
31. Difenoxin Hydrochloride 32. Difloxacin Hydrochloride 33. Entacapone – RECEIVED
34. Epoprostenol Sodium – RECEIVED 35. Erythromycin Phosphate 36. Erythromycin Thiocyanate
37. Esmolol Hydrochloride – RECEIVED 38. Estazolam – RECEIVED 39. Estramustine Phosphate Sodium
40. Ethanolamine Oleate 41. Etomidate – RECEIVED 42. Etoposide Phosphate
43. Exemestane 44. Famciclovir – RECEIVED 45. Felbamate
46. Fluoromethane F 18 47. Fosfomycin Tromethamine – RECEIVED 48. Gadobenate Dimeglumine
49. Gadopentetic Acid 50. Gallium Nitrate 51. Ganirelix
52. Glyceryl Aminobenzoate 53. Guanidine Hydrochloride 54. Halobetasol Propionate – RECEIVED
55. Haloperidol Decanoate – RECEIVED 56. Hydrocodone Polistirex 57. Ibandronate Sodium
58. Imipramine Pamoate 59. Imiquimod 60. Irinotecan Hydrochloride – RECEIVED
61. Isosulfan Blue 62. Latanoprost – RECEIVED 63. Lomustine – RECEIVED
64. Lopinavir – RECEIVED 65. Metipranolol Hydrochloride 66. Miglitol
67. Milrinone Lactate 68. Misoprostol – RECEIVED 69. Moexipril Hydrochloride
70. Nalbuphine Hydrochloride 71. Nalmefene Hydrochloride 72. Nateglinide – RECEIVED
73. Nedocromil Sodium 74. Nicardipine Hydrochloride 75. Nilutamide
76. Nisoldipine 77. Olsalazine Sodium – RECEIVED 78. Orlistat – RECEIVED
79. Oxcarbazepine – RECEIVED 80. Oxiconazole Nitrate 81. Pemirolast Potassium
82. Pentamidine Isethionate – RECEIVED 83. Pioglitazone Hydrochloride 84. Piperonyl Butoxide
85. Pirbuterol Acetate – RECEIVED 86. Poractant Alpha 87. Porfimer Sodium
88. Pramiprexole Dihydrochloride 89. Quetiapine Fumarate – RECEIVED 90. Ranitidine
91. Rivastigmine Tartrate – RECEIVED 92. Ropinirole Hydrochloride 93. Rose Bengal Disodium
94. Rosiglitazone Maleate 95. Salmeterol Xinafoate – RECEIVED 96. Sertraline Hydrochloride – RECEIVED
97. Sibutramine Hydrochloride – RECEIVED 98. Sodium Phenylbutyrate 99. Sodium Phosphates
100. Spectinomycin Sulfate 101. Streptozocin 102. Tacrolimus – RECEIVED
103. Tenofovir Disoproxil Fumarate – RECEIVED 104. Terconazole – RECEIVED 105. Tiludronate Disodium
106. Tiopronin 107. Tranexamic Acid – RECEIVED 108. Tranylcypromine Sulfate – RECEIVED
109. Trimetrexate Glucuronate 110. Venlafaxine Hydrochloride – RECEIVED 111. Voriconazole – RECEIVED
112. Zaleplon 113. Zinc Tridosium Pentetate 114. Zoledronic Acid
115. Zonisamide – RECEIVED    

For additional information, contact Karen A. Russo, Ph.D., .

Small Molecules Actives (Drug Substances) | Small Molecules Actives (Drug Products) | Excipients

MONOGRAPH NAME

Small Molecules Actives (Drug Products)

1. Abacavir Sulfate, Lamivudine, and Zidovudine Tablets 2. Acarbose Tablets 3. Acetaminophen, Butalbital, Caffeine, and Codeine Phosphate Capsules
4. Acetaminophen, Clemastine Fumarate and Pseudoephedrine Hydrochloride Tablets 5. Acetazolamide Extended–Release Capsules 6. Albuterol and Ipratropium Bromide Inhalation Aerosol
7. Albuterol and Ipratropium Bromide Inhalation Solution 8. Albuterol Extended–Release Tablets 9. Albuterol Inhalation Aerosol
10. Albuterol Sulfate Inhalation Solution 11. Albuterol Sulfate Oral Solution 12. Alendronate Sodium Oral Solution
13. Alfuzosin Extended–Release Tablets 14. Allopurinol For Injection 15. Alprazolam Extended–Release Tablets
16. Alprostadil Urethral Supository 17. Aminopropazine Fumarate and Neomycin Sulfate Tablets 18. Aminopropazine Fumarate Injection
19. Aminopropazine Fumarate Tablets 20. Aminopterin Sodium Tablets 21. Amiodarone Hydrochloride Injection
22. Amlodipine and Benazepril Hydrochloride Capsules 23. Amphotericin B Injection 24. Anagrelide Hydrochloride Capsules – RECEIVED
25. Arsenic Trioxide Injection 26. Atovaquone and Proguanil Hydrochloride Tablets 27. Atovaquone Tablets
28. Auranofin Capsules 29. Azatadine Maleate and Pseudoephedrine Sulfate Extended–Release Tablets 30. Azelaic Acid Cream
31. Azithromycin For Injection – RECEIVED 32. Azithromycin Tablets – RECEIVED 33. Baclofen Injection
34. Balsalazide Disodium Capsules 35. Beclomethasone Dipropionate Inhalation Aerosol 36. Beclomethasone Dipropionate Nasal Suspension
37. Benazepril Hydrochloride and Hydrochlorothiazide Tablets 38. Bentoquatam Topical Suspension 39. Benzocaine and Cetylpyridinium Chloride Lozenges
40. Benzocaine and Menthol Lotion 41. Benzphetamine Hydrochloride Tablets 42. Bivalirudin Injection
43. Brompheniramine Maleate, Dextromethorphan Hydrobromide and Pseudoephedrine Hcl Oral Solution 44. Budesonide Inhalation Aerosol 45. Bupivacaine and Lidocaine Hydrochlorides Injection
46. Buprenorphine Hydrochloride Injection 47. Butalbital and Acetaminophen Capsules 48. Butalbital and Acetaminophen Tablets
49. Calcipotriene Cream 50. Calcipotriene Ointment 51. Calcipotriene Topical Solution
52. Calcitriol Capsules 53. Calcitriol Oral Solution 54. Calcium Acetate Capsules
55. Calcium Trisodium Pentetate Injection 56. Calfactant Intratracheal Suspension 57. Carbidopa and Levodopa Extended–Release Tablets – RECEIVED
58. Carbidopa and Levodopa Tablets For Oral Suspension – RECEIVED 59. Carbidopa, Levidopa, and Entacapone Tablets 60. Carmustine For Injection – RECEIVED
61. Carmustine Implant 62. Cefdinir Tablets 63. Cefditoren Pivoxil Tablets
64. Ceftibuten Capsules 65. Ceftibuten For Oral Suspension 66. Ceftiofur Hydrochloride Oral Suspension
67. Cetirizine Hydrochloride Tablets – RECEIVED 68. Cetrorelix Injection 69. Cevimeline Hydrochloride Capsules
70. Chloroxine Cream 71. Chlorpromazine Hydrochloride Extended–Release Capsules 72. Choline and Magnesium Salicylates Oral Solution
73. Choline and Magnesium Salicylates Tablets 74. Choline Salicylate Oral Solution – RECEIVED 75. Ciclopirox Shampoo
76. Ciclopirox Topical Gel 77. Ciclopirox Topical Solution – RECEIVED 78. Cimetidine Oral Solution
79. Ciprofloxacin Extended–Release Tablets 80. Ciprofloxacin Hydrochloride and Hydrocortisone Otic Suspension 81. Ciprofloxacin Otic Solution
82. Cisplatin Injection 83. Citalopram Hydrobromide Oral Solution 84. Citric Acid, Gluconolactone, and Magnesium Carbonate Irrigation
85. Cladribine Injection 86. Clemastine Fumarate Syrup 87. Clobetasol Propionate Gel
88. Clorazepate Dipotassium Capsules 89. Clorazepate Dipotassium Extended–Release Tablets 90. Clotrimazole and Betamethasone Dipropionate Lotion
91. Compound Undecylenic Acid Cream 92. Compound Undecylenic Acid Topical Powder 93. Conjugated Estrogens and Medroxyprogesterone Acetate Tablets
94. Cyclosporine Modified Capsules 95. Cyclosporine Modified Oral Solution 96. Cyclosporine Ointment
97. Cyclosporine Topical Solution 98. Cysteamine Bitartrate Capsules 99. Cytarabine Liposome Injection
100. Dalfopristin and Quinupristin Injection 101. Dantrolene Sodium Oral Suspension 102. Dapiprazole For Ophthalmic Solution
103. Desirudin For Injection 104. Desonide Cream 105. Dexrazoxane For Injection
106. Dextroamphetamine Sulfate Extended–Release Capsules 107. Dextromethorphan Polistirex Extended–Release Oral Suspension 108. Diazepam Injectable Emulsion
109. Diclofenac Sodium Ophthalmic Solution 110. Diethylpropion Hydrochloride Extended–Release Tablets 111. Difenoxin Hydrochloride and Atropine Sulfate Tablets
112. Difloxacin Hydrochloride Tablets 113. Dihydroergotamine Mesylate Metered Spray 114. Diltiazem Hydrochloride Injection
115. Dinoprostone Vaginal Suppositories 116. Diphenhydramine Hydrochloride and Acetaminophen Tablets 117. Divalproex Sodium Delayed– Release Capsules
118. Dorzolamide and Timolol Ophthalmic Solution 119. Dorzolamide Ophthalmic Solution 120. Doxepin Hydrochloride Cream
121. Doxycycline Oral Gel 122. Econazole Nitrate Cream 123. Edrophonium Chloride and Atropine Sulfate Injection
124. Enalapril Maleate and Felodipine Extended – Release Tablets 125. Enalaprilat Injection – RECEIVED 126. Entacapone Tablets – RECEIVED
127. Ephedrine Sulfate and Guaifenesin Tablets 128. Epirubicin Hydrochloride For Injection 129. Epirubicin Hydrochloride Injection
130. Epoprostenol For Injection 131. Epoprostenol Injection 132. Escitalopram Oxalate Tablets – RECEIVED
133. Esmolol Hydrochloride Injection 134. Esomeprazole Magnesium Capsules 135. Estazolam Tablets – RECEIVED
136. Estramustine Phosphate Sodium Capsules 137. Ethanolamine Oleate Injection 138. Etidronate Disodium Injection Concentrate
139. Etomidate Injection 140. Exemestane Tablets 141. Famciclovir Tablets
142. Famotidine Orally Disintegrating Tablets 143. Felbamate Oral Suspension 144. Felbamate Tablets
145. Fentanyl Lozenges 146. Fentanyl Transdermal System – RECEIVED 147. Ferrous Fumarate and Docusate Sodium Extended–Release Capsules
148. Fluconazole Oral Suspension 149. Flunisolide Inhalation Aerosol 150. Flunisolide Nasal Spray
151. Fluocinolone Acetonide Shampoo 152. Fluorescein Sodium Ophthalmic Solution 153. Fluorometholone Ointment
154. Fluticasone Propionate Cream – RECEIVED 155. Fluticasone Propionate Inhalation Powder 156. Fluticasone Propionate Ointment – RECEIVED
157. Fluticasone Propionate Pressurized Inhaler 158. Foscarnet Sodium Injection 159. Fosfomycin For Oral Solution
160. Gabapentin Oral Solution 161. Gadobenate Dimeglumine Injection 162. Gallium Nitrate Injection
163. Ganciclovir Capsules 164. Ganirelix Acetate Injection 165. Gatifloxacin Injection
166. Gatifloxacin Tablets 167. Gentamicin Sulfate Oral Solution 168. Gentamicin Sulfate Soluble Powder
169. Glipizide Extended–Release Tablets 170. Guaifenesin and Pseudoephedrine Hydrochloride Extended–Release Tablets 171. Guaifenesin and Salts Of Dextromethorphan and Pseudoephedrine Oral Solution
172. Guanidine Hydrochloride Tablets 173. Halobetasol Propionate Cream 174. Halobetasol Propionate Ointment
175. Haloperidol Decanoate Injection 176. Haloperidol Lactate Injection 177. Haloperidol Lactate Oral Concentrate
178. Hydralazine Hydrochloride and Hydrochlorothiazide Capsules 179. Hydrochlorothiazide Capsules 180. Hydrochlorothiazide Oral Solution
181. Hydrocodone Bitartrate and Acetaminophen Capsules 182. Hydrocodone Bitartrate and Acetaminophen Oral Solution 183. Hydrocodone Bitartrate and Aspirin Tablets
184. Hydrocodone Bitartrate and Guaifenesin Oral Solution 185. Hydrocodone Bitartrate and Homatropine Methylbromide Syrup 186. Hydrocortisone Acetate Dental Paste
187. Hydrocortisone Acetate Rectal Foam Aerosol 188. Hydrocortisone Butyrate Lotion 189. Hydroflumethiazide and Reserpine Tablets
190. Hydromorphone Hydrochloride Oral Solution – RECEIVED 191. Hydroquinone Lotion 192. Ibandronate Sodium Tablets
193. Ibuprofen Capsules 194. Idarubicin Hydrochloride Injection 195. Imipramine Pamoate Capsules
196. Imiquimod Topical Cream 197. Ipratropium Bromide Inhalation Aerosol 198. Ipratropium Bromide Inhalation Solution
199. Irinotecan Hydrochloride Injection 200. Isosulfan Blue Injection 201. Isradipine Extended–Release Tablets
202. Itraconazole Injection 203. Itraconazole Oral Solution 204. Ketoconazole Cream
205. Ketoconazole Shampoo 206. Ketoprofen Capsules – RECEIVED 207. Ketoprofen Extended–Release Capsules
208. Ketoprofen Tablets 209. Ketotifen Fumarate Ophthalmic Solution 210. Lactic Acid Lotion
211. Lamotrigine Tablets 212. Latanoprost Ophthalmic Solution 213. Leucovorin Calcium For Injection
214. Levetiracetam Tablets 215. Levocabastine Ophthalmic Suspension 216. Levofloxacin Solution
217. Lincomycin Hydrochloride and Spectinomycin Sulfate Soluble Powder 218. Liothyronine Injection 219. Lomustine Capsules
220. Lopinavir and Ritonavir Solution 221. Lopinavir Capsules 222. Lopinavir Solution
223. Loratadine Orally– Disintegrating Tablets – RECEIVED 224. Losartan Potassium Tablets – RECEIVED 225. Mefloquine Hydrochloride Tablets
226. Melphalan For Injection 227. Mesalamine Suppositories 228. Mesoridazine Besylate Concentrate
229. Metaraminol Bitartrate Injection 230. Methacholine Chloride For Inhalation Solution 231. Methadone Hydrochloride Oral Concentrate
232. Methocarbamol and Aspirin Tablets 233. Methoxsalen Softgels 234. Methyclothiazide and Deserpidine Tablets
235. Methylphenidate Hydochloride Chewable Tablets 236. Metipranolol Ophthalmic Solution 237. Metronidazole Capsules – RECEIVED
238. Metronidazole Cream 239. Metronidazole Extended–Release Tablets 240. Metronidazole Hydrochloride For Injection
241. Metronidazole Lotion 242. Miconazole Nitrate Topical Aerosol 243. Midazolam Injection – RECEIVED
244. Mifepristone Tablets 245. Miglitol Tablets 246. Milrinone Injection
247. Misoprostol Tablets – RECEIVED 248. Moexipril Hydrochloride and Hydrochlorothiazide Tablets 249. Moexipril Hydrochloride Tablets
250. Molindone Hydrochloride Oral Solution 251. Morphine Sulfate For Injection Concentrate 252. Morphine Sulfate Oral Solution
253. Morphine Sulfate Oral Solution Concentrate 254. Morphine Sulfate Tablets 255. Mycophenolate Mofetil Capsules
256. Mycophenolate Mofetil Oral Solution 257. Mycophenolate Mofetil Tablets 258. Nalbuphine Hydrochloride Injection
259. Nalmefene Hydrochloride Injection 260. Naphazoline Hydrochloride and Pheniramine Maleate Ophthalmic Solution 261. Naproxen Sodium Extended–Release Tablets
262. Nateglinide Tablets – RECEIVED 263. Nedocromil Sodium Inhalation Aerosol 264. Neomycin Sulfate Oral Powder
265. Nicardipine Hydrochloride Capsules 266. Nilutamide Tablets 267. Nimodipine Capsules
268. Nisoldipine Extended–Release Tablets 269. Nitroglycerin Solution In Acrylic Adhesive 270. Nitroglycerin Transdermal System
271. Nizatidine Tablets 272. Ofloxacin In Dextrose Injection 273. Ofloxacin Injection
274. Olsalazine Sodium Capsules 275. Orphenadrine Citrate Extended Release Tablets – RECEIVED 276. Orphenadrine Citrate, Aspirin, and Caffeine Tablets
277. Oxcarbazepine Suspension 278. Oxcarbazepine Tablets – RECEIVED 279. Oxiconazole Cream
280. Pamidronate Disodium Injection 281. Pantoprazole Sodium For Injection 282. Pantoprazole Sodium Tablets
283. Paroxetine Hydrochloride Extended–Release Tablets 284. Paroxetine Oral Suspension 285. Pemirolast Potassium Ophthalmic Solution
286. Penicillin G Potassium Tablets For Oral Solution 287. Pentamidine Isethionate For Inhalation 288. Pentamidine Isethionate Injection – RECEIVED
289. Pentazocine Hydrochloride and Acetaminophen Tablets 290. Phendimetrazine Tartrate Extended–Release Capsules 291. Phenobarbital Capsules
292. Phentermine Resin Complex Capsules 293. Phenylephrine Hydrochloride and Chlorpheniramine Maleate Extended–Release Capsules 294. Phenylephrine Hydrochloride, Chlorpheniramine Maleate, and Acetaminophen Extended–Release Tablets
295. Pilocarpine Hydrochloride Ophthalmic Gel 296. Pilocarpine Hydrochloride Ophthalmic Ointment 297. Pioglitazone Hydrochloride Tablets
298. Piperonyl Butoxide and Pyrethrins Aerosol Foam 299. Pirbuterol Acetate Inhalation Aerosol 300. Poractant Alpha Supension
301. Porfimer Sodium For Injection 302. Povacrylate Solution 303. Povacrylate– Iodine Topical Solution
304. Povidone– Iodine Gauze 305. Povidone– Iodine Swabsticks 306. Povidone– Iodine Topical Aerosol Foam
307. Povidone– Iodine Vaginal Suppositories 308. Pramipexole Dihydrochloride Tablets 309. Prednisolone Sodium Phosphate Oral Solution
310. Prochlorperazine Maleate Extended–Release Capsules 311. Progesterone Capsules 312. Promethazine and Phenylephrine Hydrochlorides and Codeine Phosphate Syrup – RECEIVED
313. Promethazine and Phenylephrine Hydrochlorides Syrup – RECEIVED 314. Promethazine Hydrochloride and Codeine Phosphate Oral Solution – RECEIVED 315. Promethazine Hydrochloride and Dextromethorphan Hydrobromide Syrup – RECEIVED
316. Propafenone Hydrochloride Tablets 317. Pseudoephedrine Hydrochloride and Brompheniramine Maleate Extended–Release Tablets 318. Pseudoephedrine Hydrochloride and Naproxen Sodium Extended–Release Tablets
319. Pseudoephedrine Hydrochloride, Chlorpheniramine Maleate, and Codeine Phosphate Oral Solution 320. Pseudoephedrine Hydrochloride, Guaifenesin, and Codeine Phosphate Oral Solution 321. Pseudoephedrine Sulfate and Dexbrompheniramine Maleate Extended–Release Tablets
322. Pseudoephedrine Sulfate and Dexbrompheniramine Maleate Oral Solution 323. Pseudoephedrine Sulfate, Dexbrompheniramine Maleate, and Acetaminophen Extended–Release Tablets 324. Pyrilamine Maleate Injection
325. Quinapril Hydrochloride and Hydrochlorothiazide Tablets 326. Quinidine Sulfate Injection 327. Ramipril Capsules
328. Ranitidine Capsules 329. Rauwolfia Serpentina and Endroflumethiazide Tablets 330. Reserpine and Polythiazide Tablets
331. Rimantadine Hydrochloride Oral Solution 332. Risperidone Oral Solution – RECEIVED 333. Risperidone Orally Disintegrating Tablets
334. Rivastigmine Tartrate Capsules – RECEIVED 335. Rivastigmine Tartrate Oral Solution – RECEIVED 336. Rocuronium Bromide Injection
337. Ropinirole Hydrochloride Tablets 338. Rosiglitazone Maleate Tablets 339. Salicylic Acid and Sulfur Cleansing Lotion
340. Salicylic Acid and Sulfur Lotion 341. Salicylic Acid and Sulfur Shampoo 342. Salicylic Acid Cream
343. Salicylic Acid Ointment 344. Salmeterol Inhalation Aerosol 345. Salmeterol Xinafoate Inhalation Powder
346. Scopolamine Transdermal System 347. Selegiline Hydrochloride Capsules 348. Sertraline Hydrochloride Oral Solution
349. Sibutramine Hydrochloride Capsules 350. Sodium Bicarbonate and Sodium Citrate For Oral Solution 351. Sodium Bicarbonate, Sodium Citrate, and Sodium Tartrate For Oral Suspension
352. Sodium Iodide Injection 353. Sodium Phenylbutyrate Oral Powder 354. Sodium Phenylbutyrate Tablets
355. Sodium Phosphates For Oral Suspension 356. Sodium Phosphates Tablets 357. Sodium Salicylate and Sulfur Shampoo
358. Sterile Talc Aerosol 359. Streptozocin For Injection 360. Sucralfate Oral Suspension
361. Sulconazole Nitrate Cream 362. Sulfacetamide Sodium and Fluorometholone Ophthalmic Suspension 363. Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution
364. Sulfasalazine Oral Suspension 365. Sulisobenzone Lotion 366. Sumatriptan Injection
367. Sumatriptan Tablets – RECEIVED 368. Tacrolimus Capsules – RECEIVED 369. Tacrolimus Injection
370. Tacrolimus Ointment 371. Tamsulosin Hydrochloride Capsules – RECEIVED 372. Technetium Tc 99M Teboroxime Injection
373. Tenofovir Disoproxil Fumarate Tablets – RECEIVED 374. Terazosin Capsules – RECEIVED 375. Terazosin Tablets – RECEIVED
376. Terbinafine Hydrochloride Cream 377. Terbinafine Tablets – RECEIVED 378. Terbinafine Topical Solution
379. Terconazole Vaginal Cream 380. Terconazole Vaginal Suppositories 381. Testosterone Transdermal Gel
382. Testosterone Transdermal System 383. Tetracycline Hydrochloride Periodontal Fiber 384. Theophylline Extended–Release Tablets
385. Tioconazole Vaginal Ointment 386. Tiopronin Tablets 387. Tolnaftate Topical Aerosol Solution
388. Topiramate Capsules – RECEIVED 389. Topiramate Tablets – RECEIVED 390. Torsemide Injection
391. Torsemide Tablets – RECEIVED 392. Trandolapril and Verapamil Hydrochloride Extended–Release Tablets 393. Trandolapril Tablets
394. Tranexamic Acid Injection 395. Tranylcypromine Sulfate Tablets – RECEIVED 396. Tretinoin Capsules
397. Tretinoin Microsphere Gel 398. Triamcinolone Acetonide Suspension 399. Trifluridine Ophthalmic Solution
400. Trimetrexate For Injection 401. Trimipramine Maleate Capsules 402. Triprolidine and Pseudoephedrine Hydrochlorides and Codeine Phosphate Syrup
403. Trolamine Salicylate Cream 404. Trolamine Salicylate Gel 405. Trolamine Salicylate Topical Emulsion
406. Undecylenic Acid Topical Foam Aerosol 407. Urea Cream 408. Vecuronium Bromide For Injection
409. Venlafaxine Extended–Release Capsules – RECEIVED 410. Venlafaxine Tablets – RECEIVED 411. Verapamil Hydrochloride Capsules
412. Verapamil Hydrochloride Extended–Release Capsules 413. Voriconazole Injection 414. Voriconazole Oral Suspension
415. Voriconazole Tablets 416. Yttrium Y– 90 Chloride Solution 417. Yttrium Y– 90 Glass Microspheres
418. Yttrium Y– 90 Microspheres Injection 419. Zaleplon Capsules 420. Zidovudine and Lamivudine Tablets – RECEIVED
421. Zinc Acetate Capsules 422. Zinc Tridosium Pentetate Injection 423. Ziprasidone Hydrochloride Capsules
424. Zoledronic Acid For Injection 425. Zonisamide Capsules – RECEIVED  

For additional information, contact Karen A. Russo, Ph.D., .

Small Molecules Actives (Drug Substances) | Small Molecules Actives (Drug Products) | Excipients

MONOGRAPH NAME

Excipients

1. Acetone Sodium Bisulfite 2. Acetylated Monoglycerides 3. Aconitic Acid (Achilleic Acid)
4. Acrylic Acid– Octyl Acrylate Copolymer 5. Albumin Colloidal 6. Aliphatic Polyesters
7. Allantoin– Sodium Pyrrolidone Carboxylate 8. Aluminum Ammonium Sulfate 9. Aluminum Lactate
10. Aluminum Oxide 11. Aluminum Potassium Sulfate 12. Aluminum Silicate
13. Aluminum Sodium Sulfate 14. Aluminum Stearate 15. Ammonium Bicarbonate
16. Ammonium Calcium Alginate 17. Ammonium Phosphate 18. Batylalcohol Monostearate
19. Beeswax, Synthetic 20. Benzododecinium Bromide 21. Benzyl Chloride
22. Benzyl Nicotinate 23. Beta Naphthol 24. Brominated Vegetable Oil
25. Butadiene– Styrene Rubber 26. Butylated Hydromethylphenol 27. Butylene Glycol
28. Butylphthalyl Butylglycolate 29. Calcium Acid Pyrophosphate 30. Calcium Alginate
31. Calcium Alginate and Ammonium Alginate 32. Calcium Bromide 33. Calcium Chloride Solution
34. Calcium Phosphate Monobasic 35. Calcium Propionate 36. Calcium Pyrophosphate
37. Calcium Sorbate 38. Calcium Stearoyl Lactylate 39. Caldiamide Sodium
40. Calteridol Calcium 41. Capric Acid 42. Caprylic/Capric Diglyceryl Succinate
43. Carbon 44. Carboxymethyl Starch 45. Carboxymethylamylopectin Sodium
46. Carboxymethylcellulose Potassium 47. Cetostearyl Isononanoate 48. Chlorodifluoroethane
49. Cholic Acid 50. Cinnamaldehyde 51. Cocamide Diethanolamine
52. Cocamide Oxide 53. Cocoyl Caprylocaprate 54. Crystal Gum
55. Cutina 56. Cystine – RECEIVED 57. D–Mannose
58. Dammar Gum 59. Decanoic Acid 60. Decyl Oleate
61. Desoxycholic Acid – RECEIVED 62. Dextrin Palmitate 63. Dextrins Modified
64. Diacetyl Tartaric Acid Esters Of Mono– and Diglycerides 65. Dicetyl Phosphate 66. Dichlorofluoromethane
67. Diethyl Sebacate 68. Difluoroethane 69. Diglycol Stearate
70. Diisobutyl Adipate 71. Diisopropyl Adipate 72. Diisopropylbenzothiazyl– 2– Sulfenamide
73. Dilauryl Thiodipropionate 74. Dimethyl Dicarbonate 75. Dimyristoyl Lecithin
76. Dimyristoyl Phosphatidylglycerol 77. Dipropylene Glycol 78. Disodium Edisylate
79. Disodium Guanylate 80. Disodium Inosinate 81. Disodium Monooleamide Sulfasuccinate
82. Docusate Sodium/Sodium Benzoate 83. Erythrosine 84. Ethoxylated Mono– and Diglycerides
85. Ethoxyquin 86. Ethyl Hexanediol 87. Ethyl Linoleate
88. Ethyl Maltol – RECEIVED 89. Ethylene Dichloride 90. Ethylurea
91. Ferric Ammonium Citrate 92. Ferric Citrate 93. Ferric Oxide, Brown
94. Ferric Phosphate 95. Ferric Pyrophosphate 96. Ferrous Citrate
97. Ferrous Glycinate 98. Ferrous Lactate 99. Fluorochlorohydrocarbons
100. Formic Acid 101. Furcelleran 102. Gentistic Acid
103. Geraniol 104. Glutamic Acid Hydrochloride 105. Gluten
106. Glycerol Ester Of Gum Rosin (Ester Gum) 107. Glyceryl Laurate 108. Glyceryl Palmitate
109. Glyceryl Ricinoleate 110. Glyceryl Tristearate 111. Glycine Hydrochloride
112. Glycofurol 113. Glycol Stearate 114. Heptafluoropropane
115. Heptylparaben 116. Hexadecyl Isostearate 117. Hexane
118. Hexanetriol(– 1,2,6– ) 119. Hydrocarbon Gel 120. Hydroxyethylmethylcellulose
121. Hydroxylated Lecithin 122. Indigotine 123. Iron Carbonyl
124. Iron Subcarbonate 125. Isobutylated– Isoprene Copolymer 126. Isooctylacrylate
127. Isopropyl Isostearate 128. Isopropyl Stearate 129. Isostearic Acid
130. Isostearyl Alcohol 131. L– Ascorbyl Stearate 132. L– Cysteine Monohydrochloride
133. L– Glutamic Acid – RECEIVED 134. L– Leucine 135. Lactobionic Acid – RECEIVED
136. Lactose Ferrin, Bovine 137. Lactylated Fatty Acid Esters Of Glycerol and Propylene Glycol 138. Lactylic Esters Of Fatty Acids
139. Lanolin (Wool Fat), Hydrogenated 140. Lanolin Alcohols, Acetylated 141. Lanolin Hydrous
142. Lauramine Oxide 143. Lauric Myristic Diethanolamide 144. Lauric Acid
145. Lauric Diethanolamide 146. Lavender Oil 147. Lecithin, Hydroxylated
148. Linoleic Acid – RECEIVED 149. Macrogol Sorbitan Tristearate 150. Macrogolglycerol Cocoates
151. Macrogolglycerol Triisostearate 152. Magnesium Aluminum Silicate Hydrate 153. Magnesium Aspartame Dihydrate
154. Magnesium Aspartate 155. Magnesium Phosphate Tribasic 156. Magnesium Phosphate, Diabasic, Trihydrate
157. Magnesium Tartrate 158. Malt Syrup 159. Maltitol Syrup
160. Maltol Isobutyrate 161. Manganese Chloride 162. Manganese Citrate
163. Manganese Glycerophosphate 164. Manganese Hypophosphite 165. Medical Antifoam Emulsion C
166. Medronate Disodium 167. Medronic Acid 168. Methyl Chloride
169. Methylchloroisothiazolinone 170. Methylisothiazolinone 171. Microcrystalline Cellulose, Silicified – RECEIVED
172. Mineral Spirits 173. Monoisostearyl Glyceryl Ester 174. Monopotassium Glutamate Monohydrate
175. Monosodium Citrate 176. Mullein Leaf 177. Myristyl Gamma– Picolinium Chloride
178. Myristyl Lactate 179. N– Acetyl– L– Methionine 180. N– Methylpyrrolidone – RECEIVED
181. N,N– Bis(2– Hydroxyethyl)Stearamide 182. Naphtha 183. Non– Pareil Seeds
184. Nutmeg Oil 185. Octanoic Acid 186. Oxystearin
187. Pentasodium Triphosphate 188. Pentetate Calcium Trisodium 189. Pentetate Pentasodium
190. Phenprobamate 191. Phenylmercuric Acetate 192. Phenylmercuric Nitrate
193. Pine Oil 194. Polacrilin 195. Polyglycerol Esters Of Fatty Acids
196. Polyglycerol Polyricinoleic Acid 197. Polyoxyethylene Castor Oil – (USP Has 35) 198. Polyoxyl Stearate– (USP Has 40)
199. Polypropylene Oleate 200. Polypropylene Stearyl Ether 201. Polysorbate 65
202. Polyvinyl Ethylcellulose 203. Polyvinylacetal Diethylanoacetate 204. Polyvinylpolypyrrolidone
205. Potassium Acid Tartrate 206. Potassium Bromate 207. Potassium Carbonate Solution
208. Potassium Dichloroisocyanurate 209. Potassium Gibberellate 210. Potassium Glycerophospate
211. Potassium Iodate 212. Potassium Nitrite 213. Potassium Phosphate
214. Potassium Phosphate Tribasic 215. Potassium Polymetaphosphate 216. Potassium Pyrophosphate
217. Potassium Stearate 218. Potassium Sulfate 219. Potassium Sulfite
220. Potassium Tripolyphosphate 221. Propyl Propionate 222. Propylene Glycol Diacetate
223. Propylene Glycol Mono– and Diesters 224. Rice Bran Wax 225. Rosin
226. Silicone 227. Sodium Acid Pyrophosphate 228. Sodium Aluminosilicate – RECEIVED
229. Sodium Aluminum Phosphate Acidic 230. Sodium Aluminum Phosphate Basic 231. Sodium Aspartate
232. Sodium Bisulfate 233. Sodium Bisulfite 234. Sodium Carbonate Hydrate
235. Sodium Carboxymethyl Betaglucan 236. Sodium Caseinate 237. Sodium Chlorate
238. Sodium Citrate, Dibasic 239. Sodium Citrate, Monobasic 240. Sodium Dehydroacetate
241. Sodium Diacetate 242. Sodium Erythorbate 243. Sodium Ferric Pyrophosphate
244. Sodium Ferrocyanide 245. Sodium Hypophosphite – RECEIVED 246. Sodium Laureth Sulfate
247. Sodium Lauroyl Sarcosinate 248. Sodium Lauryl Sulfoacetate 249. Sodium Magnesium Aluminosilicate
250. Sodium Magnesium Silicate 251. Sodium Malate 252. Sodium Metaphosphate, Insoluble
253. Sodium Metasilicate 254. Sodium Methylate 255. Sodium Polyphosphates Glassy
256. Sodium Potassium Tripolyphosphate 257. Sodium Pyrophosphate 258. Sodium Pyrrolidone Carboxylate
259. Sodium Sesquicarbonate 260. Sodium Sesquinoleate 261. Sodium Stearoyl Lactylate
262. Sodium Thiomalate 263. Sodium Trimetaphosphate 264. Sodium Trioleate
265. Sodium Tripolyphosphate 266. Soy Polysaccharides 267. Stannous Tartrate
268. Starch, Pregelatinized Corn 269. Starch, Pregelatinized Tapioca 270. Stearalkonium Chloride
271. Stearyl Citrate 272. Stearyl Monoglyceridyl Citrate 273. Succinylated Monoglycerides
274. Sucrose Acetate Isobutyrate 275. Sucrose Fatty Acid Esters 276. Sucrose Stearate – RECEIVED
277. Sugar Fruit Fine 278. Sulfobutyl Ether Beta Cyclodextrin – RECEIVED 279. Tallow
280. Tallow Glycerides 281. Tallow Oil 282. Tetrafluoroethane
283. Thioglycerol 284. Thyme Oil 285. Tribehenin
286. Triceteareth– 4 Phosphate 287. Trichloroethylene 288. Trimyristin
289. Trisodium Citrate 290. Trolamine Lauryl Sulfate 291. Vegetable Oil
292. Wheat Flour 293. Wheat Germ Oil 294. Wheat Gluten – RECEIVED
295. Whey    

For additional information, contact Karen A. Russo, Ph.D., .

Small Molecules Actives (Drug Substances) | Small Molecules Actives (Drug Products) | Excipients