APPLICATION
NDA018531
TYPE
NDA
ORIGINAL APPROVAL
1981-10-06
LATEST ACTION
1999-08-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NITROGLYCERIN · ReferenceDiscontinued
NITROGLYCERIN 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1999-08-30Labeling · Supplement 13AP
1998-02-12Labeling · Supplement 12AP
1996-08-14Labeling · Supplement 11AP
1996-06-14Labeling · Supplement 10AP
1994-07-08Labeling · Supplement 9AP
1993-12-01Labeling · Supplement 8AP
1993-08-05Labeling · Supplement 7AP
1990-05-03Labeling · Supplement 5AP
1989-08-24Labeling · Supplement 6AP
1987-04-27Manufacturing (CMC) · Supplement 4AP
1981-10-06OriginalAP
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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