FDA's ANDA Approvals(7月27日)
公開日時 2009/07/28 04:00
FDA's ANDA Approvals |
Applicant |
Active Ingredients |
Number |
Date Approved |
Vintage |
Propoxyphene HCl, 65 mg caps. |
40-908 |
7/17/2009 |
Impax |
Digoxin, 0.125 mg and 0.25 mg tabs. |
78-556 |
7/20/2009 |
Wockhardt |
Adenosine, 3 mg/mL inj. |
90-220 |
7/20/2009 |
Actavis |
Vinorelbine, 10 mg/mL inj. |
78-011 |
7/22/2009 |
Taro |
Cetirizine HCl, 5 mg and 10 mg tabs. |
78-072 |
7/22/2009 |
Tentative Approvals |
Emcure |
Stavudine/lamivudine/nevirapine, 30 mg/150mg/200mg and 0mg/150mg/200mg tabs. |
22-342 |
7/16/2009 |
Alembic |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg tabs. |
78-894 |
7/20/2009 |
(The Pink Sheet 7月27日号より) FDAと米国製薬企業の情報満載
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