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FDA ANDA · ANDA075289

NIFEDIPINE

Sponsor: VALEANT PHARMS NORTH

APPLICATION
ANDA075289
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-27
LATEST ACTION
2015-09-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

NIFEDIPINEPrescription
NIFEDIPINE 60MG · TABLET, EXTENDED RELEASE · ORAL
NIFEDIPINEPrescription
NIFEDIPINE 30MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2015-09-08Labeling · Supplement 10 · standardAP
2002-12-16Manufacturing (CMC) · Supplement 5AP
2002-07-15Manufacturing (CMC) · Supplement 2AP
2002-06-04Manufacturing (CMC) · Supplement 4AP
2001-12-28Manufacturing (CMC) · Supplement 3AP
2001-02-06Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2000-09-27Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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