APPLICATION
ANDA072034
TYPE
ANDA
ORIGINAL APPROVAL
1988-05-24
LATEST ACTION
1999-07-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NITROGLYCERINPrescription
NITROGLYCERIN 5MG/ML · INJECTABLE · INJECTION
Approval history
1999-07-21Labeling · Supplement 12AP
1997-11-05Manufacturing (CMC) · Supplement 11AP
1996-08-14Labeling · Supplement 10AP
1996-06-13Labeling · Supplement 7AP
1996-02-28Manufacturing (CMC) · Supplement 6AP
1994-08-17Manufacturing (CMC) · Supplement 5AP
1992-11-18Labeling · Supplement 4AP
1992-05-07Manufacturing (CMC) · Supplement 3AP
1991-01-18Labeling · Supplement 2AP
1989-06-19Labeling · Supplement 1AP
1988-05-24OriginalAP
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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