← FDA Drug Approvals (Drugs@FDA)

NIFEDIPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ELITE PHARM SOLUTION · Approved 2020-11-18

Drug application

FDA Application #

ANDA212016

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

ELITE PHARM SOLUTION

Manufacturer

Elite Pharmaceutical Solution, Inc.

First approval

2020-11-18

Source

Authoritative

Drugs@FDA application overview

Machine

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