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FDA ANDA · ANDA075448

ISOSORBIDE MONONITRATE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA075448
TYPE
ANDA
ORIGINAL APPROVAL
2000-06-19
LATEST ACTION
2007-01-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

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

Approval history

2007-01-10Manufacturing (CMC) · Supplement 12AP
2007-01-10Manufacturing (CMC) · Supplement 10AP
2007-01-10Manufacturing (CMC) · Supplement 11AP
2002-03-14Manufacturing (CMC) · Supplement 9AP
2001-08-07Manufacturing (CMC) · Supplement 2AP
2001-08-07Manufacturing (CMC) · Supplement 7AP
2001-08-07Manufacturing (CMC) · Supplement 3AP
2001-08-07Manufacturing (CMC) · Supplement 1AP
2001-08-07Manufacturing (CMC) · Supplement 8AP
2001-08-07Labeling · Supplement 4AP
2000-12-07Manufacturing (CMC) · Supplement 5AP
2000-06-19Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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