FDA's ANDA Approvals（６月１日）
公開日時 2009/06/02 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Orit Labs |
Ergocalciferol, 50,000 IU caps. |
40-833 |
5/20/2009 |
| Hikma Farmaceutica |
Terbutaline sulfate, 1 mg/mL inj. |
78-630 |
5/20/2009 |
| Taro |
Sulfacetamide sodium, 10% topical lotion |
78-668 |
5/20/2009 |
| Sandoz |
Medroxyprogesterone acetate, 150 mg/mL inj. |
78-711 |
5/20/2009 |
| Hikma |
Risperidone, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tabs. |
78-740 |
5/26/2009 |
| Vintage |
Prednisolone sodium phosphate, EQ 15 mg base/5 mL oral solution |
79-010 |
5/26/2009 |
| Wockhardt |
Ranitidine, 15 mg syrup |
79-211 |
5/26/2009 |
| Dr. Reddy's |
Ranitidine, 15 mg syrup |
90-102 |
5/26/2009 |
| Novel Labs |
Polyethylene glycol 3350; sodium chloride; sodium bicarbonate; potassium chloride, 420 g; 11.2 g; 5.72 g; 1.48 g oral solution |
90-019 |
5/27/2009 |
| Sandoz |
Triamcinolone acetonide, 10 mg/mL suspension inj. |
90-166 |
5/27/2009 |
| Tentative Approvals |
| Pharmaforce |
Zoledronic acid, 4 mg/5 mL inj. |
90-330 |
5/20/2009 |
| Teva |
Montelukast sodium, 10 mg tabs. |
78-605 |
5/21/2009 |
| Teva |
Oxaliplatin, 50 mg/10 mL and 100 mg/20 mL inj. |
22-160 |
5/22/2009 |
| Fresenius Kabi Oncol |
Oxaliplatin, 50 mg and 100 mg inj. |
78-810 |
5/22/2009 |
| Ebewe |
Oxaliplatin, 5 mg/mL inj. |
78-812 |
5/22/2009 |
| Hospira |
Oxaliplatin, 50 mg and 100 mg inj. |
78-815 |
5/22/2009 |
| Sun |
Oxaliplatin, 50 mg and 100 mg inj. |
78-818 |
5/22/2009 |
| Mylan |
Montelukast sodium, 10 mg tabs. |
79-103 |
5/27/2009 |
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