FDA’ｓ ANDA Approvals（３月１日）
公開日時 2010/03/02 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Versapharm |
Ciclopirox, 8% topical solution |
78-975 |
2/17/2010 |
| Torrent |
Metformin HCl, 750 mg extended-release tabs. |
79-226 |
2/18/2010 |
| Matrix |
Baclofen, 10 mg and 20 mg tabs. |
90-334 |
2/18/2010 |
| Cadista |
Alendronate sodium, EQ 5 mg base, EQ 10 mg base, EQ 35 mg base and EQ 70 mg base tabs. |
90-557 |
2/18/2010 |
| Orchid |
Desloratadine, 5 mg tabs. |
78-357 |
2/19/2010 |
| Watson |
Ethinyl estradiol/norethindrone, 0.035 mg/0.4 mg oral-21 tabs. |
78-379 |
2/23/2010 |
| Accord |
Finasteride, 5 mg tabs. |
90-121 |
2/23/2010 |
| Mikart |
Hydrocodone bitartrate/acetaminophen, 10 mg/300 mg solution |
40-881 |
2/25/2010 |
| Paddock |
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride, 420 gm/bot; 1.48 gm/bot; 5.72 gm/bot; 11.2 gm/bot solution |
79-232 |
2/25/2010 |
| Paddock |
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous, 240 gm/bot; 2.98 gm/bot; 6.72 gm/bot; 5.84 gm/bot; 22.72 gm/bot solution |
90-712 |
2/25/2010 |
| Tentative Approvals |
| Torrent |
Donepezil HCl, 5 mg and 10 mg tabs. |
90-686 |
2/18/2010 |
| Roxane |
Naratriptan, 1 mg and 2.5 mg tabs. |
90-381 |
2/23/2010 |
| Sandoz |
Fexofenadine HCl/pseudoephedrine HCl, 60 mg/120 mg extended-release tabs. |
77-999 |
2/25/2010 |
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