FDA's ANDA Approvals（3月19日）
公開日時 2012/03/23 04:00
| FDA's ANDA Approvals |
|
|
Active Ingredients |
Number |
Date Approved |
| Glenmark |
Imiquimod, 5%, topical cream |
201-994 |
3/6/2012 |
| Boca Pharma |
Methimazole, 5 mg and 10 mg, tabs. |
202-068 |
3/7/2012 |
| Mylan |
Mesna, 100 mg/mL, inj. |
76-488 |
3/8/2012 |
| Teva |
Estradiol; norethindrone acetate, 0.5 mg and 0.1 mg, tabs. |
200-747 |
3/8/2012 |
| Emcure |
Diflunisal, 500 mg, tabs. |
202-845 |
3/8/2012 |
| Teva |
Risperidone, 0.5 mg, 1 mg and 2 mg, orally disintegrating tabs. |
76-908 |
3/12/2012 |
| Orchid Hlthcare |
Memantine HCl, 5 mg and 10 mg, tabs. |
90-044 |
3/12/2012 |
| Reddys |
Divalproex Sodium, EQ 500 mg valproic acid, extended release tabs. |
90-070 |
3/12/2012 |
| Marksans Pharma |
| Nexgen Pharma |
Glycopyrrolate, 1.5 mg, tabs. |
91-522 |
3/12/2012 |
| Tentative Approvals |
|
|
|
| Mylan |
Sildenafil Citrate, 20 mg, tabs. |
201-150 |
3/7/2012 |
| Mylan |
Sildenafil Citrate, 25 mg, 50 mg and 100 mg, tabs. |
201-171 |
3/7/2012 |
| Watson Labs |
Armodafinil, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg, tabs. |
200-156 |
3/8/2012 |
| Lupin |
Metformin HCl; repaglinide, 1 mg/500 mg and 2 mg/500 mg, tabs. |
200-624 |
3/8/2012 |
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