FDA's ANDA Approvals（８月30日）
公開日時 2010/09/01 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sandoz |
Hydrochlorothiazide/losartan potassium, 12.5 mg/100 mg tabs. |
77-940 |
8/19/2010 |
| Lyne |
Hydrocortisone, 2.5% topical cream |
40-879 |
8/20/2010 |
| Barr |
Clonidine, 0.1 mg/24 hr, 0.2 mg/24 hr and 0.3 mg/24 hr transdermal patch |
79-090 |
8/20/2010 |
| Tentative Approvals |
| Emcure |
Atazanavir sulfate, 300 mg caps. |
200-196 |
8/19/2010 |
| Sandoz |
Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg and 25 mg/100 mg tabs. |
77-940 |
8/19/2010 |
| Zydus |
Duloxetine HCl, 20 mg delayed-release caps. |
90-739 |
8/23/2010 |
| Teva |
Paricalcitol, 1 mcg, 2 mcg and 4 mcg caps. |
90-829 |
8/23/2010 |
| Phamaceutics |
Zoledronic acid, 4 mg/5 mL inj. |
91-170 |
8/23/2010 |
（The Pink Sheet ８月30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