FDA's ANDA Approvals(11月28日)
公開日時 2011/12/01 04:00
Mylan receives approval for eprosartan; more ANDAs.
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Applicant |
Active Ingredients |
Number |
Date Approved |
Mylan |
Eprosartan meslate EQ 400 mg base, EQ 600 mg base, tabs. |
202-012 |
11/16/2011 |
Aurobindo |
Lamivudine 150 mg, 300 mg, tabs. |
202-032 |
11/17/2011 |
VersaPharm |
Tranexamic acid 100 mg/mL, inj. |
202-373 |
11/17/2011 |
Alembic |
Leflunomide 10 mg, 20 mg, tabs. |
91-369 |
11/21/2011 |
(The Pink Sheet 11月28日号より) FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから