FDA's ANDA Approvals（7月4日）
公開日時 2011/07/05 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Glenmark |
Norgestimate; ethinyl estradiol; 0.18 mg and 0.035 mg; 0.215 mg and 0.035 mg; 0.25 mg and 0.035 mg tabs. |
200-494 |
6/17/2011 |
| Sun |
Sumatriptan succinate; EQ 6 mg base/0.5mL (EQ 12 mg base/mL) inj. |
90-358 |
6/21/2011 |
| Mylan |
Levofloxacin; 250 mg and 500 mg tabs. |
76-276 |
6/20/2011 |
| Teva |
Levofloxacin; 250 mg, 500 mg and 750 mg tabs. |
76-361 |
6/20/2011 |
| Dr Reddy's |
Levofloxacin; 250 mg, 500 mg and 750 mg tabs. |
76-710 |
6/20/2011 |
| Mylan |
Levofloxacin; 750 mg tabs. |
77-097 |
6/20/2011 |
| Sandoz |
Levofloxacin; 250 mg, 500 mg and 750 mg tabs. |
77-438 |
6/20/2011 |
| Lupin |
Levofloxacin; 250 mg, 500 mg and 750 mg tabs. |
78-424 |
6/20/2011 |
| Wockhardt |
Levofloxacin; 250 mg, 500 mg and 750 mg tabs. |
90-367 |
6/20/2011 |
| Torrent |
Levofloxacin; 250 mg, 500 mg and 750 mg tabs. |
90-722 |
6/20/2011 |
| Akorn |
Levofloxacin; EQ 500 mg/20mL (EQ 25 mg/mL); EQ 750 mg/30mL (EQ 25 mg/mL) inj. |
91-644 |
6/20/2011 |
| Hi Tech |
Levofloxacin; 250 mg/10 mL oral solution. |
91-678 |
6/20/2011 |
| Glenmark |
Levofloxacin; 250 mg, 500 mg and 750 mg tabs. |
200-250 |
6/20/2011 |
| Sagent |
Levofloxacin; EQ 500 mg/20 mL (EQ 25 mg/mL); EQ 750 mg/30 mL (EQ 25 mg/mL) inj. |
200-560 |
6/20/2011 |
| Aurobindo |
Levofloxacin; 250 mg, 500 mg and 750 mg tabs. |
201-043 |
6/20/2011 |
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