FDA's ANDA Approvals（５月17日）
公開日時 2010/05/18 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Cypress |
Carbinoxamine maleate, 4 mg/5 mL solution |
90-418 |
5/4/2010 |
| Emcure |
Bethanechol chloride, 5 mg, 10 mg, 25 mg and 50 mg tabs. |
91-256 |
5/4/2010 |
| Glenmark |
Trandolapril/verapamil HCl, 4 mg/240 mg extended-release tabs. |
79-135 |
5/5/2010 |
| Alembic |
Metronidazole, 750 mg extended-release tabs. |
90-222 |
5/5/2010 |
| Pharmaforce |
Zidovudine, 10 mg/mL inj. |
91-457 |
5/6/2010 |
| Barr |
Buprenorphine HCl, EQ 2 mg base and EQ 8 mg base sublingual tabs. |
90-360 |
5/7/2010 |
| Interpharm |
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. |
79-098 |
5/11/2010 |
| Akorn Strides |
Vecuronium bromide, 10 mg and 20 mg inj. |
90-243 |
5/11/2010 |
| Barr |
Estradiol/norethindrone acetate, 1 mg/0.5 mg tabs. |
79-193 |
5/11/2010 |
| Sagent Strides |
Bacitracin, 50,000 units inj. |
90-211 |
5/11/2010 |
| Versapharm |
Erythromycin, 2% pledgets |
90-215 |
5/12/2010 |
| Dr. Reddy's |
Tacrolimus, EQ 0.5 mg base, EQ 1 mg base and EQ 5 mg base caps. |
90-509 |
5/12/2010 |
| Amneal |
Albuterol sulfate, EQ 2 mg base/5 mL syrup |
79-241 |
5/12/2010 |
| Tentative Approvals |
| Sandoz |
Voriconazole, 200 mg inj. |
90-862 |
5/5/2010 |
| Mylan |
Budesonide, 3 mg caps. |
90-410 |
5/12/2010 |
| Mylan |
Rosuvastatin calcium, 5 mg, 10 mg, 20 mg and 40 mg tabs. |
79-161 |
5/12/2010 |
| Teva |
Rosuvastatin calcium, 5 mg, 10 mg, 20 mg and 40 mg tabs. |
79-166 |
5/12/2010 |
| Aurobindo |
Rosuvastatin calcium, 5 mg, 10 mg, 20 mg and 40 mg tabs. |
79-170 |
5/12/2010 |
（The Pink Sheet ５月17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