APPLICATION
ANDA074559
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-30
LATEST ACTION
2002-07-15
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NITROGLYCERINPrescription
NITROGLYCERIN 0.2MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NITROGLYCERINPrescription
NITROGLYCERIN 0.6MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NITROGLYCERINPrescription
NITROGLYCERIN 0.1MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NITROGLYCERINPrescription
NITROGLYCERIN 0.4MG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2002-07-15Manufacturing (CMC) · Supplement 5AP
2001-03-19Manufacturing (CMC) · Supplement 4AP
1999-10-27Labeling · Supplement 3AP
1998-12-22Labeling · Supplement 2AP
1997-07-30Manufacturing (CMC) · Supplement 1AP
1996-08-30OriginalAP
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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