← FDA Drug Approvals (Drugs@FDA)
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2017-12-12
Drug application
- FDA Application #
ANDA202891- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PRAMIPEXOLE DIHYDROCHLORIDE
- Generic name
- Pramipexole Dihydrochloride
- Active ingredients
- PRAMIPEXOLE DIHYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ZYDUS PHARMS
- First approval
- 2017-12-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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