FDA's ANDA Approvals（6月4日）
公開日時 2012/06/08 04:00
|
|
Active Ingredients |
Number |
Date Approved |
| Apotex |
Nevirapine, 200 mg, tabs. |
203-021 |
5/22/2012 |
| Micro Labs |
Nevirapine, 200 mg, tabs. |
203-080 |
5/22/2012 |
| Sandoz |
Atorvastatin calcium, EQ 10 mg base, EQ 20 mg base, EQ 40 mg base and EQ 80 mg base, tabs. |
77-575 |
5/29/2012 |
| Teva |
Atorvastatin calcium, EQ 10 mg base, EQ 20 mg base, EQ 40 mg base and EQ 80 mg base, tabs. |
78-773 |
5/29/2012 |
| Apotex |
Atorvastatin calcium, EQ 10 mg base, EQ 20 mg base, EQ 40 mg base and EQ 80 mg base, tabs. |
90-548 |
5/29/2012 |
| Torrent |
Levetiracetam, 500 mg and 750 mg, extended release tabs. |
91-338 |
5/29/2012 |
| Onco Therapies |
Carboplatin, 50 mg/vial, 150 mg/vial and 450 mg/vial, inj. |
91-510 |
5/29/2012 |
| Tentative Approvals |
| Pharmaforce |
Argatroban, 100 mg/mL, inj. |
91-665 |
5/23/2012 |
| Hetero Labs |
Lamivudine, 10 mg/mL oral solution |
91-475 |
5/29/2012 |
（The Pink Sheet 6月4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