FdaApplication
ANDA 203615
Identifiers
- fda_app_no: ANDA203615
Properties
| Property | Value |
|---|---|
| applicant_name | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2016-10-14 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL |
2 products