FDA's ANDA Approvals（11月21日）
公開日時 2011/11/24 04:00
Onco Therapies receives approal for carboplatin; more ANDAs.
|
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Onco Therapies |
Carboplatin 50mg/mL (10mg/mL), 150mg/mL (10 mg/mL), 450mg/mL (10mg/mL), 600mg/mL (10mg/mL), IV (infusion) |
91-063 |
11/09/2011 |
| Vintage |
Acetaminophen/Codeine Phosphate 120 mg/5 ml; 12 mg/5mL |
91-238 |
11/10/2011 |
| Watson |
Morphine Sulfate 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, extended release tabs. |
200-812 |
11/10/2011 |
| Hospira |
Imipenem/Cilastatin 500 mg/500 mg, inj. |
90-825 |
11/16/2011 |
| Hospira |
Imipenem/Cilastatin 500 mg/500 mg inj./ IV (infusion) |
91-007 |
11/16/2011 |
| Tentative Approvals |
|
|
|
| Apotex |
Olopatadine HCl 0.2% base ophthalmic sol. |
90-918 |
11/1/2011 |
（The Pink Sheet 11月21日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから