FDA'ｓ ANDA Approvals（８月９日）
公開日時 2010/08/10 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Actavis |
Bupropion HCl, 100 mg, 150 mg and 200 mg extended-release tabs. |
77-455 |
7/19/2010 |
| Actavis |
Sertraline HCl, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
78-175 |
7/21/2010 |
| Collegium |
Podofilox, 0.5% topical solution |
90-184 |
7/21/2010 |
| Glenmark |
Norethindrone acetate, 5 mg tabs. |
91-090 |
7/21/2010 |
| Wockhardt |
Metoprolol succinate, EQ 25 mg tartrate, EQ 50 mg tartrate, EQ 100 mg tartrate and EQ 200 mg tartrate extended-release tabs. |
90-615 |
7/22/2010 |
| Glenmark |
Norethindrone, 0.35 mg oral-28 tabs. |
91-209 |
7/22/2010 |
| Par |
Amlodipine besylate/benazepril HCl, EQ 2.5 mg base/10 mg, EQ 5 mg base/10 mg, EQ 5 mg base/20 mg, EQ 10 mg base/20 mg, EQ 5 mg base/40 mg and EQ 10 mg base/40 mg caps. |
78-381 |
7/29/2010 |
| Sandoz |
Ethinyl estradiol/levonorgestrel, 0.03 mg/0.15 mg oral-28 tabs. |
79-102 |
8/3/2010 |
| Glenmark |
Clotrimazole, 1% topical cream |
90-219 |
8/3/2010 |
| Strides |
Ergocalciferol, 50,000 IU caps. |
90-455 |
8/3/2010 |
| Tentative Approvals |
| Matrix |
Lamivudine/nevirapine/zidovudine, 30 mg/50 mg/60 mg oral suspension tabs. |
200-793 |
7/8/2010 |
| Alcon |
Brimonidine tartrate/timolol maleate, 0.2%/0.5% ophthalmic solution |
91-574 |
8/3/2010 |
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