FDA's ANDA Approvals（3月12日）
公開日時 2012/03/13 04:00
Generic drug approvals and tentative approvals for early March.
|
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Teva |
Progesterone, 100 mg and 200 mg, caps. |
202-121 |
2/29/2012 |
| Dr. Reddy’s |
Fenofibrate, 43 mg and 130 mg, caps. |
90-859 |
3/1/2012 |
| Lupin |
Ziprasidone HCl, EQ 20 mg base, EQ 40 mg base, EQ 60 mg base and EQ 80 mg base, caps. |
77-560 |
3/2/2012 |
| Apotex |
Ziprasidone HCl, EQ 20 mg base, EQ 40 mg base, EQ 60 mg base and EQ 80 mg base, caps. |
77-561 |
3/2/2012 |
| Dr. Reddy’s |
Ziprasidone HCl, EQ 20 mg base, EQ 40 mg base, EQ 60 mg base and EQ 80 mg base, caps. |
77-565 |
3/2/2012 |
| Nexus |
Tranexamic Acid, 100 mg/mL, inj. |
91-596 |
3/2/2012 |
| Tentative Approvals |
|
|
|
| Mylan |
Sildenafil citrate, 20 mg, tabs. |
201-150 |
3/7/2012 |
| Mylan |
Sildenafil citrate, 25 mg, 50 mg and 100 mg, tabs. |
201-171 |
3/7/2012 |
（The Pink Sheet 3月12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