← FDA Drug Approvals (Drugs@FDA)
NICARDIPINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NAVINTA LLC · Approved 2025-06-25
Drug application
- FDA Application #
ANDA218638
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NICARDIPINE HYDROCHLORIDE
- Generic name
- NICARDIPINE HYDROCHLORIDE
- Active ingredients
- NICARDIPINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- NAVINTA LLC
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- First approval
- 2025-06-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown