FDA's ANDA Approvals（11月22日）
公開日時 2010/11/24 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| West Ward |
Prednisone, 1 mg tabs. |
40-890 |
11/1/2010 |
| Watson |
Lamotrigine, 25 mg, 100 mg, 150 mg and 200 mg tabs. |
77-783 |
11/1/2010 |
| Alkem |
Metformin HCl, 500 mg, 850 mg and 1 gm tabs. |
91-184 |
11/1/2010 |
| Biokey |
Levetiracetam, 500 mg tabs. |
90-906 |
11/5/2010 |
| Impax |
Fexofenadine HCl/pseudoephedrine HCl, 60 mg/120 mg extended-release tabs. |
76-298 |
11/12/2010 |
| Vintage |
Ethinyl estradiol/norethindrone, 0.035 mg/1 mg oral-28 tabs. |
76-337 |
11/12/2010 |
| Hospira |
Gemcitabine, 2 g inj. |
79-183 |
11/15/2010 |
| Sun |
Diltiazem HCl, 120 mg, 180 mg, 240 mg, 300 mg and 360 mg extended-release caps. |
90-421 |
11/15/2010 |
| Zydus |
Indomethacin, 25 mg caps. |
90-403 |
11/15/2010 |
| Tolmar |
Ranitidine, 15 mg/mL syrup |
90-054 |
11/15/2010 |
| Vintage |
Ethinyl estradiol/norethindrone, 0.035 mg/0.5 mg tabs. |
76-338 |
11/16/2010 |
| Sun |
Desloratadine, 5 mg tabs. |
78-359 |
11/16/2010 |
| Paddock |
Trospium chloride, 20 mg tabs. |
91-573 |
11/17/2010 |
| Natco |
Trihexyphenidyl HCl, 2 mg and 5 mg tabs. |
91-630 |
11/17/2010 |
| Tentative Approvals |
| Gate |
Linezolid, 600 mg tabs. |
91-210 |
10/29/2010 |
| Dr. Reddy’s |
Fexofenadine HCl/pseudoephedrine HCl, 60 mg/120 mg extended-release tabs. |
76-667 |
11/12/2010 |
| Accord |
Finasteride, 1 mg tabs. |
91-643 |
11/15/2010 |
| Sandoz |
Rizatriptan benzoate, 5 mg and 10 mg orally disintegrating tabs. |
78-739 |
11/16/2010 |
| Torrent |
Levetiracetam, 500 mg and 750 mg extended-release tabs. |
91-338 |
11/17/2010 |
（The Pink Sheet 11月22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