FDA's ANDA Approvals（２月22日）
公開日時 2010/02/24 04:03
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Hikma |
Milrinone lactate, EQ 20 mg base/100 mL (EQ 0.2 mg base/mL) and EQ 40 mg base/200 mL (EQ 0.2 mg base/mL) inj. |
90-038 |
1/21/2010 |
| Cephazone |
Cefotaxime sodium, EQ 10 gm base/vial inj. |
65-348 |
1/25/2010 |
| Cadista |
Oxcarbazepine, 150 mg, 300 mg and 600 mg tabs. |
90-239 |
1/25/2010 |
| Lupin |
Perindopril erbumine, 2 mg, 4 mg and 8 mg tabs. |
78-263 |
1/27/2010 |
| Mylan |
Polyethylene glycol 3350, potassium chloride. sodium bicarbonate, sodium chloride, sodium sulfate anhydrous, 236 gm, 2.97 gm, 6.74 gm, 5.86 gm, 22.74 gm oral solution |
90-928 |
1/28/2010 |
| Taro |
Levetiracetam, 1gm, 750 mg, 500 mg and 250 mg tabs. |
78-960 |
2/1/2010 |
| Actavis |
Cetirizine HCl, 5 mg/5 mL syrup |
78-617 |
2/2/2010 |
| Sagent Strides |
Labetalol HCl, 5 mg/mL inj. |
79-134 |
2/3/2010 |
| Watson |
Ethinyl estradiol/norethindrone, 0.035 mg/0.5 mg; 0.75 mg/0.035 mg and 1 mg/0.035 mg tabs. |
76-393 |
2/4/2010 |
| Lupin |
Amlodipine besylate/benazepril HCl, EQ 2.5 mg base/10 mg, EQ 5 mg base/10 mg, EQ 5 mg base/20 mg, EQ 10 mg base/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg caps. |
78-466 |
2/5/2010 |
| Perrigo |
Ciclopirox, 1% topical shampoo |
78-594 |
2/16/2010 |
| Aurobindo |
Sulfamethoxazole/trimethoprim, 400 mg/80 mg and 800 mg/160 mg tabs. |
90-624 |
2/16/2010 |
| Mylan |
Ursodiol, 300 mg caps. |
90-530 |
2/17/2010 |
| Hikma |
Valproate sodium, 100 mg/mL inj. |
78-523 |
2/17/2010 |
| Tentative Approvals |
| Pliva Lachema |
Oxaliplatin, 5 mg/mL inj. |
78-943 |
1/14/2010 |
| Glenmark |
Trandolapril/verapamil HCl, 1 mg/240 mg, 2 mg/180 mg, 2 mg/240 mg and 4 mg/240 mg extended-release tabs. |
79-135 |
1/21/2010 |
| Hospira |
Zoledronic acid, 4 mg inj. |
90-621 |
1/25/2010 |
| Hospira |
Zoledronic acid, 4 mg/5mL inj. |
90-709 |
1/25/2010 |
| Torrent |
Levofloxacin, 250 mg, 500 mg and 750 mg tabs. |
90-722 |
2/17/2010 |
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