FDA's ANDA Approvals（１月４日）
公開日時 2010/01/07 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Wockhardt |
Ranitidine HCl, EQ 150 mg base and EQ 300 mg base tabs. |
78-701 |
12/11/2009 |
| Mutual Pharm |
Donepezil HCl, 5 mg and 10 mg orally disintegrating tabs. |
77-975 |
12/11/2009 |
| Aurobindo |
Cetirizine HCl, 5 mg/5 mL syrup |
90-751 |
12/16/2009 |
| Genera |
Cromolyn sodium, 100 mg/5 mL concentrate |
90-954 |
12/18/2009 |
| Ebewe |
Epirubicin HCl, 50 mg/25 mL (2 mg/mL) and 200 mg/100 mL (2 mg/mL) inj. |
65-339 |
12/22/2009 |
| Interchem |
Ampicillin sodium/sulbactam sodium, EQ 1 gm base/vial/EQ 500 mg/base/vial and EQ 2 gm base/vial/EQ 1 gm base/vial inj. |
65-406 |
12/22/2009 |
| Westward |
Ciprofloxacin, 200 mg/20 mL (10 mg/mL)and 400 mg/40 mL (10 mg/mL) inj. |
76-717 |
12/22/2009 |
| Sandoz |
Risperidone, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg orally disintegrating tabs. |
78-116 |
12/22/2009 |
| Wockhardt |
Carvedilol, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg tabs. |
78-786 |
12/22/2009 |
| Pharmaforce |
Etomidate, 2 mg/mL inj. |
78-867 |
12/22/2009 |
| Endo |
Mycophenolate mofetil, 250 mg caps. |
90-111 |
12/22/2009 |
| Generamedix |
Cosyntropin, 0.25 mg/vial inj. |
90-574 |
12/23/2009 |
| Tentative Approvals |
| Mylan |
Levofloxacin, 250 mg, 500 mg and 750 mg tabs. |
90-063 |
12/4/2009 |
| Hikma |
Rosiglitazone maleate, 2 mg, 4 mg and 8 mg tabs. |
78-658 |
12/8/2009 |
| Teva |
Gemcitabine, 2 g inj. |
90-644 |
12/8/2009 |
| Watson |
Gemcitabine, 200 mg and 1 g inj. |
78-759 |
12/22/2009 |
| Glenmark |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg tabs. |
90-781 |
12/22/2009 |
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