FDA's ANDA Approvals（11月7日）
公開日時 2011/11/11 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Innopharma |
Olanzapine 10 mg/vial inj. |
201-588 |
10/24/2011 |
| Watson |
Ethinyl estradiol; levonorgestrel 0.02 mg, 0.01 mg, 0.1 mg tabs. |
200-407 |
10/25/2011 |
| Hikma |
Cefotetan EQ 10gm base/vial inj. |
91-030 |
10/26/2011 |
| Hikma |
Cefotetan EQ 1gm base/vial, EQ 2gm base/vial inj. |
91-031 |
10/26/2011 |
| Dr. Reddys |
Mycophenolate mofetil 250 mg caps. |
91-315 |
10/27/2011 |
| Pack |
Cromolyn sodium 100 mg; 5 mL oral sol. |
202-583 |
10/27/2011 |
| Sun |
Diltiazem HCl 120 mg, 180 mg, 240 mg, 300 mg, 360 mg extended-release tabs. |
90-492 |
10/28/2011 |
| Endo |
Felodipine 2.5 mg, 5 mg, 10 mg extended release tabs. |
200-815 |
10/28/2011 |
| Apotex |
Epinastine HCl 0.05% ophthalmic sol./drops. |
90-919 |
10/31/2011 |
| Pharmaforce |
Epinastine HCl 0.05% ophthalmic sol./drops. |
90-951 |
10/31/2011 |
| Sun |
Epinastine HCl 0.05% ophthalmic sol./drops. |
91-626 |
10/31/2011 |
| Lupin |
Tramadol HCL 100 mg, 200 mg, 300 mg extended-release tabs. |
200-503 |
10/31/2011 |
| Tentative Approvals |
|
|
|
| Lupin |
Lamivudine; zidovudine 150 mg, 300 mg tabs. |
90-246 |
10/26/2011 |
| Endo |
Montelukast sodium 10 mg tabs. |
91-576 |
10/27/2011 |
| Endo |
Montelukast sodium 4 mg, 5 mg chewable tabs. |
91-588 |
10/27/2011 |
| Mylan |
Metformin HCl 500 mg, 1000 mg extended-telease tabs. |
200-690 |
10/27/2011 |
| Dr Reddys |
Zoledronic acid 5 ml/100 ml inj. |
91-364 |
10/31/2011 |
| Teva |
Solifenacin auccinate 5 mg, 10 mg tabs. |
91-464 |
10/31/2011 |
（The Pink Sheet 11月7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