FDA's ANDA Approvals（1月31日）
公開日時 2011/02/02 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Alembic |
Lamotrigine, 25 mg, 100 mg, 150 mg and 200 mg tabs. |
90-607 |
1/13/2011 |
| Dr. Reddy’s |
Pantoprazole sodium, EQ 20 mg base and EQ 40 mg base delayed-release tabs. |
77-619 |
1/19/2011 |
| G & W Labs |
Metronidazole, 0.75% topical gel |
78-178 |
1/19/2011 |
| Torrent |
Pantoprazole sodium, EQ 20 mg base and EQ 40 mg base delayed-release tabs. |
90-074 |
1/19/2011 |
| Matrix |
Pantoprazole sodium, EQ 20 mg base and EQ 40 mg base delayed-release tabs. |
90-970 |
1/19/2011 |
| Wockhardt |
Pantoprazole sodium, EQ 20 mg base and EQ 40 mg base delayed-release tabs. |
91-231 |
1/19/2011 |
| Kudco |
Pantoprazole sodium, EQ 20 mg base and EQ 40 mg base delayed-release tabs. |
78-281 |
1/20/2011 |
| Natco |
Chloroquine phosphate, EQ 300 mg base tabs. |
90-612 |
1/21/2011 |
| Natco |
Chloroquine phosphate, EQ 150 mg base tabs. |
90-621 |
1/21/2011 |
| Boca |
Acetaminophen/hydrocodone bitartrate, 300 mg/5 mg, 300 mg/7.5 mg and 300 mg/10 mg tabs. |
90-415 |
1/24/2011 |
| Mylan |
Galantamine hydrobromide, EQ 8 mg base, EQ 16 mg base and EQ 24 mg base extended-release caps. |
90-900 |
1/24/2011 |
| Teva |
Gemcitabine HCl, EQ 1 g base/vial and EQ 200 mg base/vial inj. |
77-983 |
1/25/2011 |
| Tentative Approvals |
| Alcon |
Latanoprost, 0.005% ophthalmic solution |
91-449 |
1/14/2011 |
| Akorn |
Levofloxacin, 25 mg/mL inj. |
91-644 |
1/14/2011 |
| Pliva |
Donepezil HCl, 5 mg and 10 mg tabs. |
90-425 |
1/19/2011 |
| Dr. Reddy’s |
Sumatriptan/naproxen sodium, 85 mg/500 mg tabs. |
90-930 |
1/20/2011 |
| Fresenius |
Gemcitabine, 200 mg, 1 g and 2 g inj. |
90-799 |
1/20/2011 |
| Par |
Sumatriptan/naproxen sodium, 85 mg/500 mg |
90-753 |
1/21/2011 |
| Aurobindo |
Levofloxacin, 250 mg, 500 mg and 750 mg tabs. |
201-043 |
1/24/2011 |
（The Pink Sheet 1月31日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから