FDA's ANDA Approvals （11月23日）
公開日時 2009/11/25 04:00
| FDA's ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Barr |
Fentanyl citrate, EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.0 mg base, EQ 0.8 mg base, EQ 1.2 mg base and EQ 1.6 mg base troche/lozenge transmucosal |
77-312 |
10/30/2009 |
| Mallinckrodt |
Fentanyl citrate, EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.0 mg base, EQ 0.8 mg base, EQ 1.2 mg base and EQ 1.6 mg base troche/lozenge transmucosal |
78-907 |
10/30/2009 |
| Barr |
Ethinyl estradiol/norethindrone acetate, 0.005 mg/1 mg tabs. |
76-221 |
11/6/2009 |
| Hetero |
Methocarbamol, 500 mg and 750 mg tabs. |
90-200 |
11/6/2009 |
| Par |
Tramadol HCl, 100 mg and 200 mg extended-release tabs. |
78-783 |
11/13/2009 |
| Nexgen |
Acetaminophen/butalbital/caffeine, 300 mg/50 mg/40 mg caps. |
40-885 |
11/16/2009 |
| Wockhardt |
Betaxolol, EQ 0.5% base ophthalmic solution/drops |
78-694 |
11/16/2009 |
| Sun |
Nicardipine HCl, 25 mg/10 mL (2.5 mg/mL) inj. |
78-405 |
11/17/2009 |
| Navinta |
Nicardipine HCl, 25 mg/10 mL (2.5 mg/mL) inj. |
90-125 |
11/17/2009 |
| Pharmaforce |
Nicardipine HCl, 25 mg/10 mL (2.5 mg/mL) inj. |
90-534 |
11/17/2009 |
| Generamedix |
Nicardipine HCl, 25 mg/10 mL (2.5 mg/mL) inj. |
90-664 |
11/17/2009 |
| Wockhardt |
Nicardipine HCl, 25 mg/10 mL (2.5 mg/mL) inj. |
90-671 |
11/17/2009 |
| Westward |
Ciprofloxacin, 400 mg/200 mL inj. |
78-431 |
11/18/2009 |
| Pharmaforce |
Dorzolamide HCl, EQ 2% base ophthalmic solution/drops |
79-186 |
11/18/2009 |
| Amneal |
Nizatidine, 15 mg/mL solution |
90-576 |
11/18/2009 |
| Alcon |
Dorzolamide HCl/timolol maleate, EQ 2% base/E! 0.5% base ophthalmic solution/drops |
90-604 |
11/18/2009 |
| Tentative Approvals |
| Par |
Omeprazole/sodium bicarbonate, 20 mg/1,100 mg; 40 mg/1,100 mg caps. |
78-966 |
10/30/2009 |
| Sun |
Imatinib mesylate, 100 mg and 400 mg tabs. |
78-340 |
11/13/2009 |
（The Pink Sheet 11月23日号より） FDAと米国製薬企業の情報満載
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