FDA's ANDA Approvals（9月5日）
公開日時 2011/09/06 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Apotex |
Letrozole 2.5 mg tabs |
91-303 |
8/24/2011 |
| Invagen |
Naproxen 250 mg, 375 mg, 500 mg tabs |
91-305 |
8/24/2011 |
| Apotex |
Cevimeline HCl 30 mg caps |
91-260 |
8/25/2011 |
| Perrigo Israel |
Ketoconazole 2% aerosol foam topical |
91-550 |
8/25/2011 |
| Septodont |
Prilocaine HCl/Epiniphrine 4%/1:200,000 inj. |
78-959 |
8/30/2011 |
| Sagent |
Orphenadrine Citrate 30mg/ml inj. |
90-585 |
8/30/2011 |
| Jubilant Organosys |
Pantoprazole Sodium EQ 20mg, EQ 40mg Delayed Release tabs. |
90-901 |
8/30/2011 |
| Mylan |
Promethazine HCl 12.5 mg, 25 mg, 50 mg tabs |
91-054 |
8/30/2011 |
| Tentative Approvals |
| AB |
Efavirenz 600 mg tabs |
91-579 |
8/29/2011 |
| Torrent |
Sildenafil Citrate 20 mg tabs |
91-479 |
8/30/2011 |
| Accord |
Tacrolimus .5 mg, 1 mg, 5 mg caps |
91-195 |
8-31/2011 |
（The Pink Sheet 9月5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