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FDA NDA · NDA022026

AMLODIPINE BESYLATE

Sponsor: SYNTHON PHARMS

APPLICATION
NDA022026
TYPE
NDA
ORIGINAL APPROVAL
2007-09-27
LATEST ACTION
2007-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

AMLODIPINE BESYLATE · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL
AMLODIPINE BESYLATE · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL
AMLODIPINE BESYLATE · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2007-09-27Type 3 - New Dosage Form · Original · standard — 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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