FdaApplication
ANDA 202353
Identifiers
- fda_app_no: ANDA202353
Properties
| Property | Value |
|---|---|
| applicant_name | CHARTWELL RX SCIENCES LLC |
| application_type | ANDA |
| approval_date | 2014-12-04 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL |
5 products