FDA's ANDA Approvals（８月３日）
公開日時 2009/08/04 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Hanford |
Penicillin G potassium, 1 million units/vial, 5 million units/vial and 20 million units/vial inj. |
65-149 |
7/23/2009 |
| Nexus |
Benztropine mesylate, 1 mg/mL inj. |
90-233 |
7/28/2009 |
| Roxane |
Risperidone, 1 mg/mL oral solution |
76-904 |
7/29/2009 |
| Dr. Reddy's |
Risperidone, 1 mg/mL oral solution |
78-909 |
7/29/2009 |
| Akorn |
Carboplatin, 50 mg/5 mL (10 mg/mL), 150 mg/15 mL (10 mg/mL) and 450 mg/45 mL (10 mg/mL) IV (infusion) inj. |
90-475 |
7/29/2009 |
| Barr |
Triamcinolone acetonide, 55 mcg nasal spray |
78-104 |
7/30/2009 |
| ACS Dobfar Info |
Fluconazole, 2 mg/mL inj. |
79-104 |
7/30/2009 |
| Tentative Approvals |
| Mylan |
Amlodipine besylate/benazepril HCl, 5 mg/40 mg and 10 mg/40 mg caps. |
79-047 |
7/23/2009 |
| Aurobindo |
Donepezil HCl, 5 mg and 10 mg tabs. |
90-056 |
7/28/2009 |
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