FDA's ANDA Approvals（７月12日）
公開日時 2010/07/14 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Actavis Elizabeth |
Paroxetine HCl, EQ 10 mg base, EQ 20 mg base, EQ 30 mg base and EQ 40 mg base tabs. |
76-968 |
6/21/2010 |
| Fresenius Kabi |
Anastrozole, 1 mg tabs. |
90-088 |
6/28/2010 |
| Mylan |
Anastrozole, 1 mg tabs. |
91-051 |
6/28/2010 |
| Vistapharm |
Methadone HCl, 5 mg/5 mL and 10 mg/5 mL oral solution |
90-707 |
6/30/2010 |
| Sagent |
Heparin sodium, 1,000 units/mL, 5,000 units/mL and 10,000 units/mL inj. |
90-808 |
6/30/2010 |
| Sagent |
Heparin sodium, 20,000 units/mL inj. |
90-809 |
6/30/2010 |
| Sagent |
Heparin sodium, 1,000 units/mL inj. |
90-810 |
6/30/2010 |
| Nycomed |
Adapalene, 0.1% topical cream |
90-824 |
6/30/2010 |
| Lyne |
Triamcinolone acetonide, 0.1% dental paste |
40-771 |
7/1/2010 |
| Mylan |
Doxycycline, 40 mg caps. |
90-855 |
7/1/2010 |
| Amneal |
Spironolactone, 25 mg, 50 mg and 100 mg tabs. |
91-426 |
7/2/2010 |
| Zydus |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg and 1.5 mg tabs. |
78-920 |
7/6/2010 |
| Sandoz |
Pramipexole dihydrochloride, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg tabs. |
90-190 |
7/6/2010 |
| Teva |
Naratriptan, EQ 1 mg base and EQ 2.5 mg base tabs. |
78-751 |
7/7/2010 |
| Sandoz |
Naratriptan, 1 mg and 2.5 mg tabs. |
90-288 |
7/7/2010 |
| Roxane |
Naratriptan, 1 mg and 2.5 mg tabs. |
90-381 |
7/7/2010 |
| Paddock |
Clindamycin palmitate HCl, EQ 75 mg base/5 mL oral solution |
90-902 |
7/7/2010 |
| Paddock |
Naratriptan, 1 mg and 2.5 mg tabs. |
91-326 |
7/8/2010 |
| Tentative Approvals |
| Orchid |
Gemifloxacin mesylate, 320 mg tabs. |
90-466 |
7/2/2010 |
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