APPLICATION
NDA018621
TYPE
NDA
ORIGINAL APPROVAL
1982-01-05
LATEST ACTION
1997-12-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NITRO-BIDDiscontinued
NITROGLYCERIN 5MG/ML · INJECTABLE · INJECTION
Approval history
1997-12-15Manufacturing (CMC) · Supplement 20AP
1997-09-29Labeling · Supplement 21AP
1996-11-29Labeling · Supplement 19AP
1996-07-11Labeling · Supplement 18AP
1995-06-22Manufacturing (CMC) · Supplement 17AP
1994-11-30Manufacturing (CMC) · Supplement 16AP
1993-06-21Labeling · Supplement 14AP
1992-11-18Labeling · Supplement 13AP
1989-09-21Manufacturing (CMC) · Supplement 9AP
1989-09-21Manufacturing (CMC) · Supplement 11AP
1989-09-21Manufacturing (CMC) · Supplement 8AP
1989-09-21Labeling · Supplement 10AP
1987-12-16Manufacturing (CMC) · Supplement 7AP
1985-06-14Manufacturing (CMC) · Supplement 6AP
1982-01-05OriginalAP
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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