FDA’ｓ ANDA Approvals（４月12日）
公開日時 2010/04/13 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sandoz |
Metaxalone, 800 mg tabs. |
40-445 |
3/31/2010 |
| Mylan |
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride, 420 gm/bot; 1.48 gm/bot; 5.72 gm/bot; 11.2 gm/bot oral solution |
90-409 |
4/2/2010 |
| Teva |
Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg, 12.5 mg/100 mg and 25 mg/100 mg tabs. |
77-157 |
4/6/2010 |
| Roxane |
Hydrochlorothiazide/losartan potassium, 12.5 mg/100 mg and 25 mg/100 mg tabs. |
77-732 |
4/6/2010 |
| Sun |
Bupropion HCl, 100 mg, 150 mg and 200 mg extended-release tabs. |
78-866 |
4/6/2010 |
| Torrent |
Hydrochlorothiazide/losartan potassium, 12.5 mg/100 mg tabs. |
90-528 |
4/6/2010 |
| Vintage |
Amlodipine besylate, EQ 2.5 mg base, EQ 5 mg base and EQ 10 mg base tabs. |
78-414 |
4/7/2010 |
| Aurobindo |
Venlafaxine HCl, EQ 25 mg base, EQ 37.5 mg base, EQ 50 mg base, EQ 75 mg base and EQ 100 mg base tabs. |
90-555 |
4/7/2010 |
| Tentative Approvals |
| Synthon |
Amlodipine/valsartan, 5 mg/320 mg and 10 mg/320 mg tabs. |
90-144 |
4/1/2010 |
| Mylan |
Memantine HCl, 5 mg and 10 mg tabs. |
79-225 |
4/2/2010 |
| Invagen |
Tenofovir disoproxil fumarate, 300 mg tabs. |
90-636 |
4/2/2010 |
| Sandoz |
Levofloxacin, 250 mg, 500 mg and 750 mg tabs. |
77-438 |
4/5/2010 |
| Upsher |
Losartan potassium, 25 mg, 50 mg and 100 mg tabs. |
90-544 |
4/7/2010 |
（The Pink Sheet ４月12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