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ROPINIROLE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ELITE LABS INC · Approved 2025-11-10
Drug application
- FDA Application #
ANDA217862- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ROPINIROLE HYDROCHLORIDE
- Generic name
- ROPINIROLE
- Active ingredients
- ROPINIROLE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ELITE LABS INC
- Manufacturer
- Elite Laboratories, Inc.
- First approval
- 2025-11-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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