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NIFEDIPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2022-11-18

Drug application

FDA Application #
ANDA216896
Application type
Abbreviated New Drug Application (Generic)
Brand name
NIFEDIPINE
Generic name
NIFEDIPINE
Active ingredients
NIFEDIPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
ALEMBIC
Manufacturer
Alembic Pharmaceuticals Inc.
First approval
2022-11-18

Source

Authoritative
Drugs@FDA application overview
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