APPLICATION
ANDA089773
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-30
LATEST ACTION
2001-08-13
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
MINITRANDiscontinued
NITROGLYCERIN 0.4MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2001-08-13Manufacturing (CMC) · Supplement 28AP
2000-01-18Labeling · Supplement 26AP
1999-06-11Manufacturing (CMC) · Supplement 25AP
1998-06-16Manufacturing (CMC) · Supplement 24AP
1996-08-30Labeling · Supplement 22AP
1996-08-30OriginalAP
1996-08-30Manufacturing (CMC) · Supplement 21AP
1995-12-21Manufacturing (CMC) · Supplement 23AP
1994-09-23Manufacturing (CMC) · Supplement 20AP
1993-09-24Manufacturing (CMC) · Supplement 17AP
1993-02-01Manufacturing (CMC) · Supplement 13AP
1992-09-11Bioequivalence · Supplement 12AP
1992-03-30Manufacturing (CMC) · Supplement 9AP
1992-02-25Bioequivalence · Supplement 11AP
1991-04-22Manufacturing (CMC) · Supplement 4AP
1991-04-22Manufacturing (CMC) · Supplement 3AP
1988-11-28Labeling · Supplement 1AP
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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