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NIFEDIPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS · Approved 2016-08-25

Drug application

FDA Application #

ANDA202987

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

NOVAST LABS

Manufacturer

Ingenus Pharmaceuticals, LLC

First approval

2016-08-25

Source

Authoritative

Drugs@FDA application overview

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