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FDA ANDA · ANDA075482

ENALAPRIL MALEATE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA075482
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-22
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ENALAPRIL MALEATEDiscontinued
ENALAPRIL MALEATE 20MG · TABLET · ORAL
ENALAPRIL MALEATEDiscontinued
ENALAPRIL MALEATE 5MG · TABLET · ORAL
ENALAPRIL MALEATEDiscontinued
ENALAPRIL MALEATE 10MG · TABLET · ORAL
ENALAPRIL MALEATEDiscontinued
ENALAPRIL MALEATE 2.5MG · TABLET · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 13AP
2001-10-22Manufacturing (CMC) · Supplement 5AP
2001-09-12Manufacturing (CMC) · Supplement 9AP
2001-05-25Manufacturing (CMC) · Supplement 7AP
2001-05-25Labeling · Supplement 8AP
2001-02-21Manufacturing (CMC) · Supplement 1AP
2001-02-21Manufacturing (CMC) · Supplement 6AP
2001-02-21Manufacturing (CMC) · Supplement 2AP
2000-08-22Original — Letter ↗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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