FDA's ANDA Approvals（10月５日）
公開日時 2009/10/06 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Austarpharma |
Alendronate sodium, EQ 5 mg base, EQ 10 mg base, EQ 35 mg base and EQ 70 mg base tabs. |
90-258 |
9/24/2009 |
| Zydus |
Ramipril, 1.25 mg, 2.5 mg, 5 mg and 10 mg tabs. |
90-697 |
9/24/2009 |
| Northstar |
Atenolol, 25 mg, 50 mg and 100 mg tabs. |
78-254 |
9/25/2009 |
| Vintage |
Cetirizine HCl, 5 mg/5 mL syrup |
78-496 |
9/25/2009 |
| Gland Pharma |
Ondansetron HCl, EQ 2 mg base/mL inj. |
79-224 |
9/25/2009 |
| Hetero |
Lithium carbonate, 150 mg, 300 mg and 600 mg caps. |
90-702 |
9/25/2009 |
| Breckenridge |
Cilostazol, 50 mg and 100 mg tabs. |
77-708 |
9/28/2009 |
| Teva |
Dorzolamide HCl/timolol maleate, EQ 2% base/EQ 0.5% base ophthalmic solution/drops |
78-704 |
9/28/2009 |
| Wockhardt |
Tomolol maleate, EQ 0.25% base and EQ 0.5% base ophthalmic solution/drops |
78-771 |
9/28/2009 |
| Mylan |
Carbidopa/levodopa, 10 mg/100 mg; 25 mg/100 mg and 25 mg/250 mg tabs. |
90-324 |
9/28/2009 |
| Hospira |
Oxaliplatin, 50 mg/vial and 100 mg/vial inj. |
78-815 |
9/30/2009 |
| Luitpold |
Metoprolol tartrate, 1 mg/mL inj. |
90-386 |
9/30/2009 |
| Tentative Approvals |
| Aurobindo |
Atomoxetine HCl, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg caps. |
79-016 |
9/16/2009 |
| Bedford |
Zoledronic acid, 4 mg/5 mL inj. |
78-768 |
9/25/2009 |
| Wockhardt |
Alfuzosin HCl, 10 mg extended-release tabs. |
90-221 |
9/30/2009 |
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