FDA's ANDA Approvals（2月13日）
公開日時 2012/02/15 04:00
Approvals of generic drugs and tentative approvals in late January and early February.
|
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Emcure |
Benzphetamine HCl, 50 mg, tabs. |
202-061 |
1/27/2012 |
| Onco Therapies |
Cytarabine, 100 mg/mL, inj. |
201-784 |
1/30/2012 |
| Pharmaforce |
Llevetiracetam, 500 mg/5 ml (100 mg/mL) IV inj. |
202-143 |
1/31/2012 |
| Apotex |
Tizanidine HCl, EQ 2 mg base, EQ 4 mg base and EQ 6 mg base, caps. |
78-868 |
2/3/2012 |
| Actavis Totowa |
Carboplatin, 50 mg/5 mL (10mg/ml), 150 mg/15 mL (10mg/ml), 450 mg/45 mL (10mg/ml) and 600 mg/60 mL (10mg/ml) IV inj. |
78-732 |
2/6/2012 |
| Apotex |
Ropinirole HCl, EQ 0.25 mg base, EQ 0.5 mg base, EQ 1 mg base, EQ 2 mg base, EQ 3 mg base, EQ 4 mg base and EQ 5 mg base, tabs. |
79-165 |
2/7/2012 |
| Mylan |
Doxycycline hyclate, EQ 150 mg base, delayed-release tabs. |
91-052 |
2/8/2012 |
| Tentative Approvals |
|
|
|
| Dr Reddy’s Labs |
Ropinirole, 2 mg, 4 mg, 6 mg, 8 mg and 12 mg, extended-release tabs. |
201-576 |
2/2/2012 |
| Macleods |
Lamivudine/nevirapine/zidovudine, 150 mg/ 200 mg/300 mg, tabs. |
202-589 |
2/8/2012 |
（The Pink Sheet 2月13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