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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
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