FdaApplication
NDA 021443
Identifiers
- fda_app_no: NDA021443
Properties
| Property | Value |
|---|---|
| applicant_name | ASPEN PHARMA USA INC |
| application_type | NDA |
| approval_date | 2004-05-10 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 0.9MG | TABLET;ORAL |
| ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 0.45MG | TABLET;ORAL |
| ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 0.3MG | TABLET;ORAL |
| ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
5 products