FDA's ANDA Approvals（９月７日）
公開日時 2009/09/08 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Cypress |
Ranitidine HCl, EQ 15 mg base/mL syrup |
78-684 |
8/27/2009 |
| Hikma |
Cephalexin, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL oral suspension |
65-444 |
8/28/2009 |
| Actavis Totowa |
Bicalutamide, 50 mg tabs. |
78-634 |
8/28/2009 |
| Watson |
Levonorgestrel, 0.75 mg tabs. |
78-665 |
8/28/2009 |
| Wockhardt |
Cetirizine HCl, 5 mg/5 mL syrup |
78-757 |
8/28/2009 |
| Hikma Farmaceutica |
Benztropine mesylate, 1 mg/mL inj. |
90-287 |
8/31/2009 |
| Barr |
Phentermine HCl, 37.5 mg tabs. |
90-470 |
8/31/2009 |
| Hospira |
Heparin sodium, 1,000 units/mL, 5,000 units/mL and 10,000 units/mL inj. |
90-571 |
8/31/2009 |
| Watson |
Ethinul estradiol/norethindrone acetate, 0.02 mg/1 mg tabs |
78-267 |
9/1/2009 |
| Tentative Approvals |
| Cipla |
Irbesartan, 75 mg, 150 mg and 300 mg tabs. |
77-205 |
8/31/2009 |
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