FdaApplication
ANDA 075809
Identifiers
- fda_app_no: ANDA075809
Properties
| Property | Value |
|---|---|
| applicant_name | DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2001-07-16 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ENPRESSE-21 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET;ORAL-21 |
| ENPRESSE-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET;ORAL-28 |
2 products