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FDA NDA · NDA021435

AMVAZ

Sponsor: DR REDDYS LABS INC

APPLICATION
NDA021435
TYPE
NDA
ORIGINAL APPROVAL
2003-10-31
LATEST ACTION
2003-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMVAZDiscontinued
AMLODIPINE MALEATE 5MG · TABLET · ORAL
AMVAZDiscontinued
AMLODIPINE MALEATE 10MG · TABLET · ORAL
AMVAZDiscontinued
AMLODIPINE MALEATE 2.5MG · TABLET · ORAL

Approval history

2003-10-31Type 2 - New Active Ingredient · Original · standard — 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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