FDA’ｓ ANDA Approvals（５月10日）
公開日時 2010/05/12 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Dr. Reddy's |
Irinotecan HCl, 40 mg/2 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL) inj. |
78-953 |
4/15/2010 |
| Teva |
Tamsulosin HCl, 0.4 mg caps |
77-630 |
4/27/2010 |
| Sandoz |
Tamsulosin HCl, 0.4 mg caps. |
78-015 |
4/27/2010 |
| Zydus |
Tamsulosin HCl, 0.4 mg caps. |
78-225 |
4/27/2010 |
| Synthon |
Tamsulosin HCl, 0.4 mg caps. |
78-801 |
4/27/2010 |
| Wockhardt |
Tamsulosin HCl, 0.4 mg caps. |
78-938 |
4/27/2010 |
| Sandoz |
Vancomycin HCl, EQ 500 mg base/vial and EQ 1 gm base/vial inj. |
90-250 |
4/27/2010 |
| Mylan |
Tamsulosin HCl, 0.4 mg caps. |
90-408 |
4/27/2010 |
| Sigmapharm |
Protriptyline HCl, 5 mg and 10 mg tabs. |
90-462 |
5/3/2010 |
| Mylan |
Bupropion HCl, 150 mg extended-release tabs. |
90-941 |
5/3/2010 |
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