FDA's ANDA Approvals（８月17日）
公開日時 2009/08/18 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Aurobindo |
Carisoprodol, 350 mg tabs. |
40-792 |
8/6/2009 |
| Fresenius Kabi Oncol |
Oxaliplatin, 50 mg/vial and 100 mg/vial IV inj. |
78-810 |
8/7/2009 |
| Ebewe Pharma |
Oxaliplatin, 50 mg/10 mL (5 mg/mL) and 100 mg/20 mL (5 mg/mL) IV inj. |
78-812 |
8/7/2009 |
| Hospira |
Oxaliplatin, 50 mg/10 mL (5 mg/mL) and 100 mg/20 mL (5 mg/mL) IV inj. |
78-813 |
8/7/2009 |
| Sun |
Oxaliplatin, 50 mg/vial and 100 mg/vial IV inj. |
78-818 |
8/7/2009 |
| Sandoz |
Tacrolimus, EQ 0.5 mg base, EQ 1 mg base and EQ 5 mg base caps. |
65-461 |
8/10/2009 |
| Ranbaxy |
Sumatriptan succinate, EQ 25 mg base and EQ 50 mg base tabs. |
76-554 |
8/10/2009 |
| Dr. Reddy's |
Sumatriptan succinate, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
76-847 |
8/10/2009 |
| Cobalt |
Sumatriptan succinate, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
76-933 |
8/10/2009 |
| Sandoz |
Sumatriptan succinate, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
76-976 |
8/10/2009 |
| Mylan |
Sumatriptan succinate, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
77-744 |
8/10/2009 |
| Hikma |
Sertraline HCl, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
77-864 |
8/10/2009 |
| Roxane |
Sumatriptan succinate, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
78-241 |
8/10/2009 |
| Orchid |
Sumatriptan succinate, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
78-284 |
8/10/2009 |
| Sun |
Sumatriptan succinate, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
78-295 |
8/10/2009 |
| Aurobindo |
Sumatriptan succinate, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base tabs. |
78-327 |
8/10/2009 |
| Dow |
Benzoyl peroxide/clindamycin phosphate, 5%/EQ 1% base topical gel |
65-443 |
8/11/2009 |
| Pharmaforce |
Ofloxacin, 0.3% otic solution/drops |
90-395 |
8/11/2009 |
| Tentative Approvals |
| Strides Arcolab |
Lamivudine, 150 mg and 300 mg tabs. |
90-457 |
8/6/2009 |
| Mustafa Nevsat IIAC Sanayll A.S. |
Oxaliplatin, 5 mg/mL inj. |
78-816 |
8/7/2009 |
| Matrix |
Efavirenz/emtricitabine/tenofovir disoproxil fumarate, 600 mg/200 mg/300 mg tabs. |
90-437 |
8/12/2009 |
（The Pink Sheet ８月17日号より） FDAと米国製薬企業の情報満載
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