FDA'ｓ ANDA Approvals（８月２日）
公開日時 2010/08/03 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sandoz |
Enoxaparin sodium, 30 mg/0.3 mL (100 mg/mL), 40 mg/0.4 mL (100 mg/mL), 60 mg/0.6 mL (100 mg/mL), 80 mg/0.8 mL (100 mg/mL), 100 mg/mL (100 mg/mL), 120 mg/0.8 mL (150 mg/mL) and 150 mg/mL (150 mg/mL) subcutaneous inj. |
77-857 |
7/23/2010 |
| Invagen |
Cyclobenzaprine HCl, 5 mg and 10 mg tabs. |
90-478 |
7/23/2010 |
| Tris |
Methylphenidate HCl, 5 mg/5 mL and 10 mg/5 mL oral solution |
91-601 |
7/23/2010 |
| Unichem |
Bisoprolol fumarate/hydrochlorothiazide, 2.5mg/6.25 mg, 5 mg/6.25 mg and 10 mg/6.25 mg tabs. |
79-106 |
7/28/2010 |
| Aurobindo |
Ranitidine HCl, EQ 15 mg base/mL syrup |
90-623 |
7/28/2010 |
| Sagent |
Sumatriptan succinate, EQ 6 mg base/0.5 mL (EQ 12 mg base/mL) subcutaneous inj. |
90-641 |
7/28/2010 |
| Methapharm |
Levetiracetam, 250 mg, 500 mg, 750 mg and 1 gm tabs. |
90-767 |
7/28/2010 |
| Akorn |
Carboplatin, 600 mg/60 mL (10 mg/mL) IV inj. |
91-268 |
7/28/2010 |
| Sagent |
Rocuronium bromide, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) inj. |
91-458 |
7/28/2010 |
| Tentative Approvals |
| Glenmark |
Fluocinonide, 0.1% topical cream |
91-282 |
7/21/2010 |
| Actavis |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-382 |
7/28/2010 |
| Glenmark |
Riluzole, 50 mg tabs. |
91-394 |
7/28/2010 |
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