APPLICATION
NDA020144
TYPE
NDA
ORIGINAL APPROVAL
1981-10-19
LATEST ACTION
2000-09-20
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
TRANSDERM-NITRO · ReferenceDiscontinued
NITROGLYCERIN 0.8MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
TRANSDERM-NITRO · ReferenceDiscontinued
NITROGLYCERIN 0.4MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
TRANSDERM-NITRO · ReferenceDiscontinued
NITROGLYCERIN 0.1MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
TRANSDERM-NITRO · ReferenceDiscontinued
NITROGLYCERIN 0.6MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
TRANSDERM-NITRO · ReferenceDiscontinued
NITROGLYCERIN 0.2MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2000-09-20Labeling · Supplement 19 · standardAP
1999-02-03Labeling · Supplement 18 · standardAP
1998-10-15Manufacturing (CMC) · Supplement 17AP
1997-10-23Manufacturing (CMC) · Supplement 16AP
1996-12-10Manufacturing (CMC) · Supplement 14AP
1996-02-27Manufacturing (CMC) · Supplement 8AP
1996-02-27Manufacturing (CMC) · Supplement 2AP
1996-02-27Manufacturing (CMC) · Supplement 7AP
1996-02-27Manufacturing (CMC) · Supplement 5AP
1996-02-27Manufacturing (CMC) · Supplement 3AP
1981-10-19UNKNOWN · Original · unknownAP
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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