FDA's ANDA Approvals（11月30日）
公開日時 2009/12/01 04:00
| Applicant |
Active Ingredients |
Number |
| Aurobindo |
Cefotaxime sodium, EQ 10 gm base/vial inj. |
65-516 |
| Aurobindo |
Cefotaxime sodium, EQ 500 mg base/vial, EQ 1 gm base/vial and EQ 2 gm base/vial inj. |
65-517 |
| Apotex |
Ketorolac tromethamine, 0.5% ophthalmic solution/drops |
76-109 |
| Alcon |
Ketorolac tromethamine, 0.5% ophthalmic solution/drops |
76-583 |
| Apotex |
Ketorolac tromethamine, 0.4% ophthalmic solution/drops |
77-308 |
| Akorn |
Ketorolac tromethamine, 0.4% ophthalmic solution/drops |
78-399 |
| Akorn |
Ketorolac tromethamine, 0.5% ophthalmic solution/drops |
78-434 |
| Alcon |
Ketorolac tromethamine, 0.4% ophthalmic solution/drops |
78-721 |
| Sun |
Ketorolac tromethamine, 0.5% ophthalmic solution/drops |
90-017 |
| Mikart |
Benzonatate, 100 mg, 150 mg and 200 mg caps. |
40-851 |
| Generamedix |
Azithromycin, EQ 500 mg base/vial inj. |
65-501 |
| Teva |
Lansoprazole, 15 mg and 30 mg delayed rel pellets caps. |
77-255 |
| Ivax |
Perindopril erbumine, 2 mg, 4 mg and 8 mg tabs. |
78-138 |
| Aurobindo |
Perindopril erbumine, 2 mg, 4 mg and 8 mg tabs. |
79-070 |
| Roxane |
Perindopril erbumine, 2 mg, 4 mg and 8 mg tabs. |
90-072 |
| Glenmark |
Ciclopirox, 0.77% topical cream |
90-273 |
| Ebewe |
Irinotecan HCl, 40 mg/2 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL) inj. |
90-137 |
| Sun |
Cetirizine HCl, 5 mg/mL syrup |
90-191 |
| Hi Tech |
Calcipotriene, 0.005% topical solution |
77-579 |
| Tolmar |
Calcipotriene, 0.005% topical solution |
77-029 |
| Luitpold |
Caffeine citrate, EQ 30 mg base/3 mL (EQ 10 mg base/mL) oral solution |
90-064 |
| Tentative Approvals |
|
|
| Cipla |
Lopinavir/ritonavir, 200 mg/50 mg tabs. |
（The Pink Sheet 11月30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