FDA's ANDA Approvals（3月28日）
公開日時 2011/03/30 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Watson |
Famciclovir, 125 mg, 250 mg and 500 mg tabs. |
78-278 |
3/21/2011 |
| Roxane |
Famciclovir, 125 mg, 250 mg and 500 mg tabs. |
90-128 |
3/21/2011 |
| Aurobindo |
Famciclovir, 125 mg, 250 mg and 500 mg tabs. |
91-114 |
3/21/2011 |
| Apotex |
Latanoprost, 0.005% ophthalmic solution/drops |
77-697 |
3/22/2011 |
| Watson |
Aspirin/oxycodone, 325 mg/4.8355 mg tabs. |
90-084 |
3/22/2011 |
| Vintage |
Torsemide, 5 mg, 10 mg, 20 mg and 100 mg tabs. |
90-613 |
3/22/2011 |
| Hi Tech |
Ranitidine, 15 mg/mL solution |
91-078 |
3/22/2011 |
| Alcon |
Latanoprost, 0.005% ophthalmic solution/drops |
91-449 |
3/22/2011 |
| Pharmaforce |
Latanoprost, 0.005% ophthalmic solution/drops |
200-925 |
3/22/2011 |
| Bausch & Lomb |
Latanoprost, 0.005% ophthalmic solution/drops |
201-006 |
3/22/2011 |
| Zydus |
Propranolol HCl, 60 mg, 80 mg 120 mg and 160 mg extended-release caps. |
90-321 |
3/23/2011 |
| Bedford |
Aztreonam, 1 g and 2 g inj. |
65-286 |
3/23/2011 |
| Hitech |
Lidocaine HCl, 2% topical jelly |
40-837 |
3/23/2011 |
| Tentative Approvals |
|
|
|
| Teva |
Lamivudine, 150 mg and 300 mg tabs. |
78-636 |
3/22/2011 |
| Orchid |
Eszopiclone, 1 mg, 2 mg and 3 mg tabs. |
91-113 |
3/22/2011 |
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