FDA's ANDA Approvals（４月27日）
公開日時 2009/04/28 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Ebewe Parenta |
Methotrexate sodium, EQ 1 g base/40 mL (EQ 25 mg base/mL) inj. |
90-029 |
4/1/2009 |
| IPCA |
Hydrochlorothiazide, 12.5 mg cap. |
79-237 |
4/2/2009 |
| Silarx |
Levetiracetam, 100 mg/mL oral solution |
90-263 |
4/3/2009 |
| Barr |
Norethindrone/ethinyl estradiol/ferrous fumarate, 0.4 mg/0.035 mg chewable tabs. |
78-965 |
4/7/2009 |
| Generamedix |
Fomepizole, 1.5 g/1.5 mL (1 g/mL) inj. |
79-033 |
4/7/2009 |
| Glenmark |
Amlodipine besylate, EQ 2.5 mg base, EQ 5 mg base and EQ 10 mg base tabs. |
78-552 |
4/8/2009 |
| Sun |
Oxycodone HCl, 5 mg, 15 mg and 30 mg tabs. |
90-659 |
4/10/2009 |
| Bedford |
Ondansetron HCl, EQ 0.64 mg base/mL inj. |
78-291 |
4/13/2009 |
| Generamedix |
Mitoxantrone HCl, EQ 20 mg base/10 mL (EQ 2 mg base/mL) and EQ 30 mg base/15 mL (EQ 2 mg base/mL) inj. |
78-980 |
4/13/2009 |
| Alcon |
Dorzolamide HCl, EQ 2% base ophthalmic solution/drops |
78-981 |
4/13/2009 |
| Barr |
Topiramate, 15 mg and 25 mg caps. |
76-448 |
4/15/2009 |
| Cobalt |
Topiramate, 15 mg and 25 mg caps. |
77-868 |
4/15/2009 |
| Mutual |
Doxycycline, EQ 50 mg base, EQ 75 mg base and EQ 100 mg base tabs. |
65-471 |
4/17/2009 |
| Dr. Reddy's |
Omeprazole, 40 mg delayed-release pellets caps. |
78-490 |
4/17/2009 |
| Tentative Approvals |
| Teva |
Ibandronate sodium, 1 mg inj. |
79-194 |
4/3/2009 |
| Dr. Reddy's |
Ranitidine, 15 mg/mL syrup |
90-102 |
4/10/2009 |
| Apotex |
Zoledronic acid, 4 mg inj. |
78-533 |
4/15/2009 |
| Zydus |
Topiramate, 15 mg and 25 mg caps. |
78-877 |
4/15/2009 |
| Sandoz |
Topiramate, 15 mg and 25 mg caps. |
79-206 |
4/15/2009 |
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