FDA's ANDA Approvals（８月10日）
公開日時 2009/08/17 14:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Pharmaforce |
Betamethasone acetate/betamethasone sodium phosphate, 3 mg/mL and EQ 3 mg base/mL inj. |
90-747 |
7/31/2009 |
| Watson |
Metoprolol succinate, EQ 50 mg tartrate extended-release tabs. |
76-862 |
8/3/2009 |
| Watson |
Metoprolol succinate, EQ 25 mg tartrate extended-release tabs. |
77-118 |
8/3/2009 |
| Teva |
Divalproex sodium, EQ 500 mg valproic acid extended-released tabs. |
78-700 |
8/3/2009 |
| APP |
Idarubicin HCl, 1 mg/mL inj. |
65-440 |
8/4/2009 |
| Tentative Approvals |
| Sandoz |
Oxaliplatin, 5 mg/mL inj. |
78-817 |
8/3/2009 |
| Cipla |
Efavirenz, 200 mg caps. |
90-155 |
8/3/2009 |
（The Pink Sheet ８月10日号より） FDAと米国製薬企業の情報満載
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