FDA’s ANDA Approvals（６月28日）
公開日時 2010/06/29 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Versapharm |
Clindamycin phosphate, EQ 1% base topical solution |
65-513 |
6/17/2010 |
| Sun |
Alprazolam, 0.25 mg, 0.5 mg, 1 mg and 2 mg tabs. |
90-082 |
6/17/2010 |
| APP |
Aztreonam, 500 mg/vial, 1 gm/vial and 2 gm/vial inj. |
65-439 |
6/18/2010 |
| Hospira |
Articaine HCl/epinephrine bitartrate, 4%/EQ 0.017 mgbase/1.7 mL (4%/EQ 0.01 mg base/mL) inj. |
79-138 |
6/18/2010 |
| Sanochemia |
Iopamidol, 61% and 76% inj. |
90-394 |
6/18/2010 |
| Mylan |
Nifedipine, 30 mg, 60 mg and 90 mg extended-release tabs. |
90-649 |
6/21/2010 |
| APP |
Ganciclovir sodium, EQ 500 mg base/vial inj. |
90-658 |
6/21/2010 |
| Hospira |
Meropenem, 500 mg/vial and 1 gm/vial inj. |
90-940 |
6/22/2010 |
| Watson |
Hydrocodone bitartrate/ibuprofen, 5 mg/200 mg tabs. |
77-454 |
6/23/2010 |
| Indicus |
Glipizide/metformin HCl, 2.5 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg tabs. |
78-728 |
6/23/2010 |
| Amneal |
Lorazepam, 0.5 mg, 1 mg and 2 mg tabs. |
78-826 |
6/23/2010 |
| Sun |
Lithium carbonate, 300 mg tabs. |
91-027 |
6/24/2010 |
| Tentative Approvals |
| APP |
Pemetrexed, 500 mg inj. |
90-384 |
6/18/2010 |
| Akorn |
Nedocromil sodum, 2% ophthalmic slution |
90-638 |
6/21/2010 |
| Watson |
Fentanyl, 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg buccal tabs. |
79-075 |
6/22/2010 |
（The PInk Sheet ６月28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