FDA’ｓ ANDA Approvals（４月26日）
公開日時 2010/04/27 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sagent Strides |
Mesna, 100 mg/mL intravenous inj. |
90-913 |
4/13/2010 |
| Dr Reddy's |
Amlodipine besylate/benazepril HCl, EQ 2.5 mg base/10 mg; EQ 5 mg base/10 mg; EQ 5 mg base/20 mg and EQ 10 mg base/20 mg caps. |
77-183 |
4/15/2010 |
| Watson |
Metoprolol succinate, EQ 100 mg tartrate and EQ 200 mg tartrate extended-release tabs. |
77-298 |
4/15/2010 |
| Invagen |
Carbinoxamine maleate, 4 mg tabs. |
90-135 |
4/15/2010 |
| Emcure |
Ondansetron HCl, EQ 2 mg base/mL inj. |
90-424 |
4/16/2010 |
| Lupin |
Imipramine pamoate, EQ 75 mg HCl, EQ 100 mg HCl, EQ 125 mg HCl and EQ 150 mg HCl caps. |
90-444 |
4/16/2010 |
| Sagent Strides |
Metoprolol tartrate, 1 mg/mL inj. |
90-317 |
4/19/2010 |
| Tentative Approvals |
| Upsher Smith |
Memantine HCl, 5 mg and 10 mg tabs. |
90-043 |
4/15/2010 |
| Aurobindo |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-083 |
4/15/2010 |
| Orchid |
Modafinil, 100 mg and 200 mg tabs. |
78-963 |
4/16/2010 |
| Roxane |
Montelukast sodium, 4 mg and 5 mg chewable tabs. |
91-128 |
4/19/2010 |
（The Pink Sheet ４月26日号より） FDAと米国製薬企業の情報満載
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