FDA's ANDA Approvals（3月26日）
公開日時 2012/03/28 04:00
| FDA's ANDA Approvals |
|
|
Active Ingredients |
Number |
Date Approved |
| Ivax |
Escitalopram oxalate, EQ 5 mg base, EQ 10 mg base and EQ 20 mg base, tabs. |
76-765 |
3/14/2012 |
| Amneal Pharms |
Escitalopram oxalate EQ 5 mg base/5 ml, oral soluiton |
202-227 |
3/14/2012 |
| Dr. Reddy’s |
Divalproex sodium, EQ 250 mg valproic acid, extended release tabs. |
90-161 |
3/15/2012 |
| Sun Pharm |
Methylphenidate HCl, 5 mg, 10 mg and 20 mg, tabs. |
90-710 |
3/15/2012 |
| Anchen |
Venlafaxine HCl, 37.5 mg, 75 mg and 150 mg, extended release caps. |
78-087 |
3/16/2012 |
| Apotex |
Ibandronate sodium, EQ 150 mg base, tabs. |
78-948 |
3/19/2012 |
| Mylan |
Ibandronate sodium, EQ 150 mg base, tabs. |
78-995 |
3/19/2012 |
| Orchid Hlthcare |
Ibandronate sodium, EQ 150 mg base, tabs. |
78-998 |
3/19/2012 |
| Tentative Approvals |
| Tolmar |
Adapalene, 0.3% topical gel |
200-298 |
3/14/2012 |
（The Pink Sheet 3月26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