FDA'ｓ ANDA Approvals（８月16日）
公開日時 2010/08/18 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Vintage |
Venlafaxine HCl, EQ 25 mg base, EQ 37.5 mg base, EQ 50 mg base, EQ 75 mg base and EQ 100 mg base tabs. |
90-027 |
8/4/2010 |
| Orchid |
Levetiracetam, 1 gm tabs. |
90-484 |
8/5/2010 |
| Lannett |
Ondansetron HCl, EQ 2 mg base/mL inj. |
90-883 |
8/5/2010 |
| Ranbaxy |
Risperidone, 0.5 mg, 1 mg and 2 mg orally disintegrating tabs. |
77-542 |
8/6/2010 |
| Ranbaxy |
Risperidone, 3 mg and 4 mg orally disintegrating tabs. |
78-474 |
8/6/2010 |
| Aurobindo |
Ranitidine HCl, EQ 15 mg base/mL syrup |
90-623 |
2008/10/10 |
| Apotex |
Losartan potassium/hydrochlorothiazide, 50 mg/12.5 mg; 100 mg/12.5 mg and 100 mg/25 mg tabs. |
90-150 |
8/11/2010 |
| Tentative Approvals |
| MacLeods |
Lamivudine/stavudine, 150 mg/30 mg tabs. |
22-541 |
8/5/2010 |
| Synthon |
Letrozole, 2.5 mg tabs. |
90-196 |
8/9/2010 |
| Apotex |
Losartan potassium/hydrochlorothiazide, 50 mg/12.5 mg and 100 mg/25 mg tabs. |
90-150 |
8/11/2010 |
| Apotex |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-790 |
8/11/2010 |
（The Pink Sheet ８月16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