FDA's ANDA Approvals（1月30日）
公開日時 2012/02/02 04:00
Generic drug approvals and tentative approvals for late January.
|
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Inventia Hlthcare |
Metformin HCl, 500 mg, extended-release tabs. |
201-991 |
1/18/2012 |
| Douglas |
Isotretinoin, 10 mg, 20 mg and 40 mg, caps. |
76-485 |
1/19/2012 |
| Sun |
Hydrochlorothiazide/ metoprolol tartrate, 25 mg/ 50 mg; 25 mg/100 mg and 50mg/100 mg, tabs. |
90-654 |
1/19/2012 |
| Glenmark Generics |
Ethinyl estradiol/norethindrone, 0.035 mg/1 mg, tabs. |
91-634 |
1/19/2012 |
| Glenmark Generics |
Ethinyl estradiol/ norethindrone 0.5 mg/0.035 mg; 0.75 mg/ 0.035 mg; 1 mg/0.035 mg tabs. |
91-636 |
1/19/2012 |
| Aurobindo |
Amoxicillin; clavulanate potassium, 875 mg; eq 125 mg base, tabs. |
91-568 |
1/20/2012 |
| Aurobindo |
Amoxicillin/clavulanate potassium, 250 mg eq 125 mg base and 500 mg/eq 125 mg base, tabs. |
91-569 |
1/20/2012 |
| Tentative Approvals |
|
|
|
| Mylan |
Armodafinil, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg, tabs. |
200-043 |
1/19/2012 |
| Micro Labs |
Efavirenz, 50 mg and 200 mg, caps. |
202-042 |
1/19/2012 |
| Mylan |
Nevirapine, 200 mg, tabs. |
202-523 |
1/24/2012 |
（The Pink Sheet 1月30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