FDA's ANDA Approvals （11月16日）
公開日時 2009/11/17 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Apotex |
Ketorolac tromethamine, 0.5% ophthalmic solution/drops |
76-109 |
11/5/2009 |
| Alcon |
Ketorolac tromethamine, 0.5% ophthalmic solution/drops |
76-583 |
11/5/2009 |
| Apotex |
Ketorolac tromethamine, 0.4% ophthalmic solution/drops |
77-308 |
11/5/2009 |
| Akorn |
Ketorolac tromethamine, 0.4% ophthalmic solution/drops |
78-399 |
11/5/2009 |
| Akorn |
Ketorolac tromethamine, 0.5% ophthalmic solution/drops |
78-434 |
11/5/2009 |
| Alcon |
Ketorolac tromethamine, 0.4% ophthalmic solution/drops |
78-721 |
11/5/2009 |
| Mikart |
Benzonatate, 100 mg, 150 mg and 200 mg caps. |
40-851 |
11/9/2009 |
| Generamedix |
Azithromycin, EQ 500 mg base/vial inj. |
65-501 |
11/9/2009 |
| Teva |
Lansoprazole, 15 mg and 30 mg delayed rel pellets caps. |
77-255 |
11/10/2009 |
| Ivax |
Perindopril erbumine, 2 mg, 4 mg and 8 mg tabs. |
78-138 |
11/10/2009 |
| Aurobindo |
Perindopril erbumine, 2 mg, 4 mg and 8 mg tabs. |
79-070 |
11/10/2009 |
| Roxane |
Perindopril erbumine, 2 mg, 4 mg and 8 mg tabs. |
90-072 |
11/10/2009 |
| Ebewe |
Irinotecan HCl, 40 mg/2 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL) inj. |
90-137 |
11/10/2009 |
| Glenmark |
Ciclopirox, 0.77% topical cream |
90-273 |
11/10/2009 |
| Sun |
Cetirizine HCl, 5 mg/mL oral syrup |
90-191 |
11/12/2009 |
（The Pink Sheet 11月16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