# PRAMIPEXOLE DIHYDROCHLORIDE
> **ANDA204518** · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2019-01-02
## Drug
- **FDA Application Number:** ANDA204518
- **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:** ALEMBIC
- **Manufacturer:** Alembic Pharmaceuticals Limited
- **First approval:** 2019-01-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204518)
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