FDA's ANDA Approvals（3月21日）
公開日時 2011/03/23 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Dr. Reddy’s |
Desloratadine, 5 mg tabs. |
78-365 |
3/8/2011 |
| Watson |
Ethinyl estradiol/norgestimate, 0.025 mg/0.18 mg, 0.025 mg/0.215 mg and 0.025 mg/0.25 mg oral-28 tabs |
90-479 |
3/9/2011 |
| Watson |
Ethinyl estradiol/norgestimate, 0.025 mg/0.215 mg and 0.025 mg/0.25 mg, tabs |
90-479 |
3/9/2011 |
| Rhodes |
Oxycodone HCl, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tabs. |
97-490 |
3/9/2011 |
| Versapharm |
Desoximetasone, 0.05% topical gel |
90-727 |
3/10/2011 |
| Cypress |
Epinastine HCl, 0.05% ophthalmic solution/drops |
90-870 |
3/14/2011 |
| Actavis |
Valacyclovir HCl, 500 mg and 1 g tabs. |
90-370 |
3/16/2011 |
| IPCA |
Allopurinol, 100 mg and 300 mg tabs. |
90-637 |
3/16/2011 |
| Coastal |
Oxycodone/aspirin, 4.8355 mg/325 mg tabs. |
91-670 |
3/16/2011 |
| Tentative Approvals |
|
|
|
| Barr |
Olopatadine HCl, 0.2% ophthalmic solution |
90-848 |
3/8/2011 |
| Cobalt |
Ibandronate sodium, 2.5 mg tabs. |
79-002 |
3/15/2011 |
| Cobalt |
Ibandronate sodium, 150 mg tabs. |
79-003 |
3/15/2011 |
| Cobrek |
Doxercalciferol, 2 mcg/mL inj. |
90-040 |
3/15/2011 |
| Sandoz |
Dexmedetomidine HCl, 100 mcg inj. |
91-465 |
3/15/2011 |
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