FDA's ANDA Approvals（7月25日）
公開日時 2011/07/26 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Indicus |
Acetazolamide, 500 mg extended release caps. |
90-779 |
7/14/2011 |
| Glaxosmith
kline |
Propranolol HCl, 60 mg, 80 mg, 120 mg, & 160 mg extended release caps. |
78-703 |
7/15/2011 |
| Glenmark |
Nizatidine, 150 mg & 300 mg caps. |
90-618 |
7/15/2011 |
| Sun |
Anastrozole, 1 mg tabs. |
91-177 |
7/15/2011 |
| Mallinckrodt |
Morphine sulfate, 100mg/5ml oral solution. |
202-348 |
7/15/2011 |
| Mustafa NEVSAT |
Methylprednisolone sodium succinate, EQ 40mg,125mg,500 mg, 1 gm, 2gm base/ vial inj. |
40-888 |
7/18/2011 |
| Apotex Inc |
Alfuzosin hydrochloride, 10mg tabs |
79-013 |
7/18/2011 |
| Mylan |
Alfuzosin hydrochloride, 10mg tabs |
79-014 |
7/18/2011 |
| Torrent Pharms |
Alfuzosin hydrochloride, 10mg tabs |
79-054 |
7/18/2011 |
| Teva Pharms |
Alfuzosin hydrochloride, 10mg tabs |
79-056 |
7/18/2011 |
| Sun Pharma Global |
Alfuzosin hydrochloride, 10mg tabs |
79-057 |
7/18/2011 |
| Boca Pharma |
Acetaminophen; Hydrocodone bitartrate, 325mg; 7.5 mg / 15ml |
40-894 |
7/19/2011 |
| Paddock Labs |
Latanoprost, .005% Ophthalmic drops |
90-887 |
7/19/2011 |
| Tentative Approvals |
|
|
|
| Watson |
Levetiracetam, 500 mg & 750 mg, extended release tabs. |
91-093 |
7/14/2011 |
| Dr Reddys |
Duloxetine HCl, 20 mg, 30 mg & 60 mg delayed release caps. |
90-723 |
7/15/2011 |
（The Pink Sheet 7月25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