FDA's ANDA Approvals（4月18日）
公開日時 2011/04/19 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Generamedix |
Sodium ferric gluconate complex, 62.5 mg/5mL inj. |
78-215 |
3/31/2011 |
| Roxane |
Exemstane, 25 mg tabs. |
77-431 |
4/1/2011 |
| Unichem |
Divalproex sodium, EQ 125 mg, EQ 250 mg and EQ 500 mg valproic acid delayed-release tabs. |
79-163 |
4/5/2011 |
| Actavis Totowa |
Lamotrigine, 25 mg, 100 mg, 150 mg and 200 mg |
78-669 |
4/8/2011 |
| Silarx |
Theophylline, 80 mg/15 mL solution |
91-156 |
4/13/2011 |
| Paddock |
Calcium acetate, EQ 160 mg calcium tabs. |
91-561 |
4/13/2011 |
| Tentative Approvals |
|
|
|
| Mylan |
Cyclobenzaprine HCl, 15 mg and 30 mg extended-release caps. |
90-738 |
3/31/2011 |
| Hitech |
Levofloxacin, 25 mg/mL oral solution |
91-678 |
4/5/2011 |
| Hitech |
Brimonidine tartrate/timolol maleate, 0.2%/0.5% ophthalmic solution |
91-086 |
4/6/2011 |
| Actavis |
Donepezil HCl, 5 mg and 10 mg tabs. |
90-551 |
4/13/2011 |
| Teva |
Zolmitriptan, 2.5 mg and 5 mg tabs. |
90-861 |
4/13/2011 |
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