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FDA ANDA · ANDA075155

ISOSORBIDE MONONITRATE

Sponsor: CHARTWELL MOLECULAR

APPLICATION
ANDA075155
TYPE
ANDA
ORIGINAL APPROVAL
1998-10-30
LATEST ACTION
2014-09-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

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

Approval history

2014-09-24Manufacturing (CMC) · Supplement 34 — Label ↗AP
2004-11-09Labeling · Supplement 28AP
2001-01-26Manufacturing (CMC) · Supplement 20AP
2000-08-04Manufacturing (CMC) · Supplement 17AP
2000-08-04Labeling · Supplement 13AP
2000-08-04Manufacturing (CMC) · Supplement 11AP
2000-08-04Manufacturing (CMC) · Supplement 16AP
2000-08-04Manufacturing (CMC) · Supplement 12AP
2000-08-04Manufacturing (CMC) · Supplement 10AP
2000-06-30Manufacturing (CMC) · Supplement 18AP
2000-01-13Manufacturing (CMC) · Supplement 5AP
2000-01-13Labeling · Supplement 3AP
2000-01-13Manufacturing (CMC) · Supplement 4AP
2000-01-13Manufacturing (CMC) · Supplement 2AP
1999-12-14Manufacturing (CMC) · Supplement 14AP
1999-07-27Manufacturing (CMC) · Supplement 7AP
1999-07-27Labeling · Supplement 8AP
1999-07-27Manufacturing (CMC) · Supplement 6AP
1999-05-14Manufacturing (CMC) · Supplement 1AP
1998-10-30Original — 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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