FDA's ANDA Approvals（3月7日）
公開日時 2011/03/08 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Zydus |
Galantamine, 4 mg, 8 mg and 12 mg tabs. |
78-898 |
2/17/2011 |
| Impax |
Doxycycline, 150 mg caps. |
200-065 |
2/17/2011 |
| Hi Tech |
Gabapentin, 250 mg/5 mL oral solution |
78-974 |
2/18/2011 |
| Coastal |
Oxycodone HCl, 5 mg, 15 mg and 30 mg tabs. |
91-313 |
2/18/2011 |
| Ranbaxy |
Ondansetron, 4 mg and 8 mg |
78-602 |
2/24/2011 |
| Glenmark |
Levocetirizine dihydrochloride, 5 mg tabs. |
90-385 |
2/24/2011 |
| Dr. Reddy’s |
Levocetirizine dihydrochloride, 5 mg tabs. |
90-392 |
2/24/2011 |
| Vintage |
Desogestrel/ethinyl estradiol, 0.15 mg/0.03 mg oral-28 tabs. |
76-675 |
2/25/2011 |
| Vintage |
Desogestrel/ethinyl estradiol, 0.15 mg/0.03 mg tabs. |
76-697 |
2/25/2011 |
| Watson |
Divalproex sodium, EQ 500 mg base valproic acid delayed-release tabs. |
79-080 |
2/25/2011 |
| Petnet |
Fludeoxyglucose F-18, 20-200 mCi/mL intravenous inj. |
79-086 |
2/25/2011 |
| KVK |
Cyclobenzaprine HCl, 5 mg and 10 mg tabs. |
78-048 |
2/28/2011 |
| Indicus |
Glyburide, 1.25 mg, 2.5 mg and 5 mg tabs. |
90-937 |
2/28/2011 |
| Tolmar |
Imiquimod, 5% topical cream |
91-044 |
2/28/2011 |
| Jubilant Life |
Lamotrigine, 5 mg and 25 mg chewable tabs. |
200-220 |
2/28/2011 |
| Indicus |
Naratriptan HCl, EQ 1 mg base and EQ 2.5 mg base tabs. |
200-502 |
2/28/2011 |
| Tentative Approvals |
|
|
| Watson |
Norgestimate/ethinyl estradiol, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg and 0.25 mg/0.025 mg tabs. |
90-479 |
2/17/2011 |
| Aurobindo |
Venlafaxine HCl, 37.5 mg, 75 mg and 150 mg extended-release caps. |
200-834 |
2/17/2011 |
（The Pink Sheet 3月7日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから