FDA's ANDA Approvals（10月31日）
公開日時 2011/11/02 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Mylan |
Morphine sulfate 15 mg, 30 mg, 60 mg, 100 mg, 200 mg extended release tabs. |
200-824 |
10/18/2011 |
| Boca |
Glycopyrrolate 1 mg, 2 mg tabs. |
90-020 |
10/19/2011 |
| Bioniche |
Dexrazoxane HCl EQ 250 mg base/vial, EQ 500mg base/vial inj. |
200-752 |
10/19/2011 |
| Austar |
Methocarbamol 500 mg, 750 mg tabs. |
200-958 |
10/21/2011 |
| Teva |
Olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg tabs. |
76-000 |
10/24/2011 |
| Par |
Olanzapine 5 mg, 10 mg, 15 mg, 20 mg orally disintegrating tabs. |
78-109 |
10/26/2011 |
| Apotex |
Olanzapine 5 mg, 10 mg, 15 mg, 20 mg orally disintegrating tabs. |
91-265 |
10/24/2011 |
| Lannett |
Diethylpropion HCl 75 mg extended release tabs. |
91-680 |
10/24/2011 |
| Dr. Reddy |
Olanzapine 5 mg, 10 mg, 15 mg, 20 mg orally disintegrating tabs. |
76-534 |
10/25/2011 |
| Teva |
Memantine HCl 5 mg, 10 mg tabs |
90-052 |
10/25/2011 |
| Mikart |
Dextroamphetamine sulfate 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg tabs. |
90-533 |
10/26/2011 |
| Torrent |
Olanzapine 5 mg, 10 mg, 15 mg, 20 mg orally disintegrating tabs. |
91-415 |
10/25/2011 |
| Acs Dobfar |
Meropenem 500 mg/vial, 1 gm/vial inj. |
91-404 |
10/26/2011 |
| Lupin |
Levonorgestrel/ ethinyl estradiol/ethinyl estradiol 0.1mg/0.02mg/0.01 mg tabs. |
91-674 |
10/26/2011 |
（The Pink Sheet 10月31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