← FDA Drug Approvals (Drugs@FDA)
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: XIAMEN LP PHARM CO · Approved 2021-06-11
Drug application
- FDA Application #
ANDA212797- 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
- XIAMEN LP PHARM CO
- Manufacturer
- Vitruvias Therapeutics, Inc.
- First approval
- 2021-06-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown