← FDA DRUG APPROVALS

FDA ANDA · ANDA075269

NIFEDIPINE

Sponsor: VALEANT PHARMS NORTH

APPLICATION
ANDA075269
TYPE
ANDA
ORIGINAL APPROVAL
2000-12-04
LATEST ACTION
2012-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

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

Approval history

2012-03-09Labeling · Supplement 10AP
2002-12-16Manufacturing (CMC) · Supplement 6AP
2002-07-15Manufacturing (CMC) · Supplement 2AP
2002-07-15Manufacturing (CMC) · Supplement 5AP
2002-02-14Manufacturing (CMC) · Supplement 1AP
2001-12-28Manufacturing (CMC) · Supplement 3AP
2000-12-04Original — 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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