FDA's ANDA Approvals（5月30日）
公開日時 2011/05/31 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Nostrum |
Carbamazepine, 100 mg, 200 mg and 300 mg extended-release caps. |
76-697 |
5/20/2011 |
| Aurobindo |
Piperacillin/tazobactam, EQ 2 gm base/vial/EQ 250 mg base/vial; EQ 3 gm base/vial/EQ 375 mg base/vial and EQ 4 gm base/vial/EQ 500 mg base/vial inj. |
65-498 |
5/23/2011 |
| Teva |
Eszopiclone, 1 mg, 2 mg and 3 mg tabs. |
91-169 |
5/23/2011 |
| Taro |
Meprobamate, 200 mg and 400 mg tabs. |
200-998 |
5/23/2011 |
| Teva |
Lamivudine/zidovudine, 150 mg/300 mg tabs. |
79-081 |
5/25/2011 |
| Invagen |
Warfarin sodium, 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg and 10 mg tabs. |
90-935 |
5/25/2011 |
| Amneal |
Risperidone, 1 mg/mL oral solution |
91-384 |
5/25/2011 |
| Tentative Approvals |
|
|
|
| Zydus |
Desloratadine, 5 mg tabs. |
78-353 |
5/23/2011 |
| Strides Arcolab |
Tenofovir disoproxil fumarate, 300 mg tabs. |
90-742 |
5/25/2011 |
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