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FDA ANDA · ANDA090598

ISOSORBIDE MONONITRATE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA090598
TYPE
ANDA
ORIGINAL APPROVAL
2010-08-11
LATEST ACTION
2010-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ISOSORBIDE MONONITRATEDiscontinued
ISOSORBIDE MONONITRATE 120MG · TABLET, EXTENDED RELEASE · ORAL
ISOSORBIDE MONONITRATEDiscontinued
ISOSORBIDE MONONITRATE 30MG · TABLET, EXTENDED RELEASE · ORAL
ISOSORBIDE MONONITRATEDiscontinued
ISOSORBIDE MONONITRATE 60MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2010-08-11OriginalAP
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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