FDA’ｓ ANDA Approvals（３月15日）
公開日時 2010/03/16 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Glenmark |
Ropinirole HCl, EQ 0.25 mg base, EQ 0.5 mg base, EQ 1 mg base, EQ 2 mg base, EQ 3 mg base, EQ 4 mg base and EQ 5 mg base tabs. |
90-135 |
2/25/2010 |
| Zydus |
Hydralazine HCl, 10 mg, 25 mg, 50 mg and 100 mg tabs. |
40-858 |
2/26/2010 |
| Hikma |
Cefoxitin sodium, EQ 10 gm base/vial inj. |
65-239 |
2/26/2010 |
| Barr |
Temozolomide, 5 mg, 20 mg, 100 mg, 250 mg, 140 mg and 180 mg caps. |
78-879 |
3/1/2010 |
| Impax |
Tamsulosin HCl, 0.4 mg caps. |
90-377 |
3/2/2010 |
| Wockhardt |
Levetiracetam, 100 mg/mL oral solution. |
90-028 |
3/3/2010 |
| Taro |
Fluorouracil, 5% topical cream |
90-368 |
3/5/2010 |
| Tentative Approvals |
| Teva |
Fluvastatin, 20 mg and 40 mg caps. |
78-407 |
3/3/2010 |
（The Pink Sheet ３月15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