FDA's ANDA Approvals（4月4日）
公開日時 2011/04/06 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Glenmark |
Ethinyl Estradiol/norethindrone, 0.035 mg/0.4 mg oral-28 tabs. |
90-538 |
3/22/2011 |
| Mylan |
Latanoprost, 0.005% ophthalmic solution/drops |
201-786 |
3/22/2011 |
| Roxane |
Bicalutamide, 50 mg tabs. |
78-285 |
3/24/2011 |
| G & W |
Calcipotriene, 0.005% topical solution |
78-468 |
3/24/2011 |
| Mylan |
Famciclovir, 125 mg, 250 mg and 500 mg tabs. |
201-333 |
3/24/2011 |
| Zydus |
Propranolol HCl, 60 mg, 80 mg, 120 mg and 160 mg extended-release caps. |
90-321 |
3/25/2011 |
| Taro |
Ondansetron HCl, EQ 4 mg base, EQ 8 mg base and EQ 24 mg base tabs. |
77-729 |
3/28/2011 |
| Sandoz |
Drospirenone/ethinyl estradiol, 3 mg/0.02 mg tabs. |
79-221 |
3/28/2011 |
| Sandoz |
Drospirenone/ethinyl estradiol, 3 mg/0.03 mg oral-28 tabs. |
90-114 |
3/28/2011 |
| Mylan |
Divalproex sodium, 125 mg valproic acid delayed release pellet caps. |
90-407 |
3/28/2011 |
| Sigmapharm |
Disulfiram, 250 mg and 500 mg tabs. |
91-619 |
3/28/2011 |
| Aurobindo |
Galantamine, 4 mg, 8 mg and 12 mg tabs. |
90-957 |
3/29/2011 |
| Sandoz |
Meropenem, 500 mg/vial and 1 gm/vial inj. |
91-201 |
3/29/2011 |
| Sandoz |
Idarubicin HCl, 1 mg/mL inj. |
91-293 |
3/29/2011 |
| Mylan |
Risperidone, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg orally-disintegrating tabs. |
91-537 |
3/30/2011 |
| Watson |
Nateglinide, 60 mg and 120 mg tabs. |
77-462 |
3/30/2011 |
| Aurobindo |
Fosinopril sodium, 10 mg, 20 mg and 40 mg tabs. |
91-163 |
3/30/2011 |
| Tentative Approvals |
| Roxane |
Irbesartan/hydrochlorothiazide, 150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25 mg tabs. |
90-351 |
3/24/2011 |
| Teva |
Ribavirin, 40 mg/mL oral solution |
77-611 |
3/28/2011 |
| Matrix |
Efavirenz, 600 mg tabs. |
91-471 |
3/28/2011 |
| Cipla |
Emtricitabine, 200 mg caps. |
91-168 |
3/29/2011 |
| Perrigo |
Minoxidil, 5% topical foam aerosol |
91-344 |
3/30/2011 |
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