FDA's ANDA Approvals（７月20日）
公開日時 2009/07/22 04:30
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Teva |
Galantamine hydrobromide, EQ 4 mg base, EQ 8 mg base and EQ 12 mg base tabs. |
77-587 |
7/9/2009 |
| JHP |
Sumatriptan succinate, EQ 6 mg base/0.5 mL (EQ 12 mg base/mL) subcutaneous inj. |
77-871 |
7/9/2009 |
| Apotex |
Flecainide acetate, 50 mg, 100 mg and 150 mg tabs. |
79-164 |
7/9/2009 |
| Aurobindo |
Fosinopril sodium/hydrochlorothiazide, 10 mg/12.5 mg and 20 mg/12.5 mg tabs. |
79-245 |
7/9/2009 |
| Invagen |
Fosinopril sodium/hydrochlorothiazide, 10 mg/12.5 mg and 20 mg/12.5 mg tabs. |
90-228 |
7/9/2009 |
| Pharmalucence |
Technetium TC-99M sestamibi kit, inj. |
79-157 |
7/10/2009 |
| Bausch & Lomb |
Dorzolamide HCl/timolol maleate, 2%/0.5% (base) ophthalmic solution |
90-037 |
7/14/2009 |
| Mutual Pharma |
Liothyronine sodium, 5 mcg, 25 mcg and 50 mcg tabs. |
90-326 |
7/14/2009 |
| Tentative Approvals |
| Mylan |
Polyethylene glycol 3350, 17 g IV solution powder |
78-915 |
7/14/2009 |
（The Pink Sheet ７月20日号より） FDAと米国製薬企業の情報満載
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