FDA's ANDA Approvals （11月9日）
公開日時 2009/11/10 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Hisamitsu |
Fentanyl, 25 ugm/hr, 50 ugm/hr, 75 ugm/hr and 100 ugm/hr extended-release transdermal film |
77-775 |
10/16/2009 |
| Sandoz |
Risperidone, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tabs. |
78-528 |
10/16/2009 |
| APP |
Chlorothiazide sodium, EQ 50 mg base/vial inj. |
90-896 |
10/16/2009 |
| Synthon |
Risperidone, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tabs. |
78-187 |
10/22/2009 |
| Generamedix |
Melphalan HCl, EQ 50 mg base/vial inj. |
90-299 |
10/27/2009 |
| Amneal Pharms |
Levetiracetam, 100 mg/mL oral solution |
90-992 |
10/27/2009 |
| Mylan |
Sumatriptan succinate, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
77-163 |
11/2/2009 |
| Aurobindo |
Lamotrigine, 5 mg and 25 mg tabs. |
90-401 |
11/4/2009 |
| Tentative Approvals |
| Zydus |
Atomoxetine HCl, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg caps. |
79-017 |
10/19/2009 |
| Roxane |
Perindopril erbumine, 2 mg, 4mg and 8 mg tabs. |
90-072 |
10/21/2009 |
| Teva |
Rosiglitazone maleate/glimepiride, 4 mg/1 mg; 4 mg/2 mg; 4 mg/4 mg; 8 mg/2 mg and 8 mg/4 mg tabs. |
78-709 |
11/2/2009 |
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