FDA's ANDA Approvals（2月20日）
公開日時 2012/02/22 04:00
Generic drug approvals and tentative approvals for mid-February.
|
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sandoz |
Cisatracurium besylate preservative-free, EQ 2 mg base/mL and EQ 10 mg base/mL, inj. |
200-154 |
2/3/2012 |
| Sandoz |
Cisatracurium besylate, EQ 2 mg base/mL, inj. |
200-159 |
2/3/2012 |
| Emcure Pharms |
Acarbose, 25 mg, 50 mg and 100 mg, tabs. |
202-271 |
2/7/2012 |
| Mylan |
Desloratadine, 5 mg tabs. |
78-351 |
2/10/2012 |
| Emcure |
Irinotecan HCl, 40 mg/2 mL (20 mg/mL), 100 mg/5 mL (20 mg/mL) and 100 mg/5 mL, inj. |
200-771 |
2/14/2012 |
| Onco Therapies |
Doxorubicin HCl, 2 mg/mL, inj. |
200-901 |
2/14/2012 |
| Sun Pharm |
Doxorubicin HCl, 2 mg/mL, inj. |
91-418 |
2/15/2012 |
| Tentative Approvals |
|
|
|
| Torrent Pharms |
Moxifloxacin HCl, 400 mg, tabs. |
200-160 |
2/15/2012 |
| Anchen Pharms |
Tramadol HCl, 100 mg, 200 mg and 300 mg, extended release tabs. |
200-491 |
2/15/2012 |
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