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FDA ANDA · ANDA075556

ENALAPRIL MALEATE

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA075556
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-22
LATEST ACTION
2016-04-12
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

2016-04-12Labeling · Supplement 6 · standardAP
2016-04-12Labeling · Supplement 5 · standardAP
2001-10-01Manufacturing (CMC) · Supplement 3AP
2001-06-08Manufacturing (CMC) · Supplement 1AP
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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