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FDA NDA · NDA019970

NITROGLYCERIN IN DEXTROSE

nitroglycerin

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA019970
TYPE
NDA
ORIGINAL APPROVAL
1989-12-29
LATEST ACTION
2016-08-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NITROGLYCERIN IN DEXTROSE 5% · ReferencePrescription
NITROGLYCERIN 20MG/100ML · INJECTABLE · INJECTION
NITROGLYCERIN IN DEXTROSE 5% · ReferencePrescription
NITROGLYCERIN 40MG/100ML · INJECTABLE · INJECTION
NITROGLYCERIN IN DEXTROSE 5% · ReferencePrescription
NITROGLYCERIN 10MG/100ML · INJECTABLE · INJECTION

Approval history

2016-08-22Labeling · Supplement 18 · standard — Label ↗AP
2015-06-17Manufacturing (CMC) · Supplement 16 · standardAP
2014-10-02Labeling · Supplement 15 · standard — Letter ↗AP
2013-12-31Manufacturing (CMC) · Supplement 14AP
2013-02-01Manufacturing (CMC) · Supplement 12 · standardAP
2000-10-06Labeling · Supplement 11 · standardAP
1999-04-21Labeling · Supplement 10 · standardAP
1998-12-09Labeling · Supplement 9 · standardAP
1995-11-03Labeling · Supplement 8 · standardAP
1995-03-24Labeling · Supplement 7 · standardAP
1994-09-29Manufacturing (CMC) · Supplement 6 · standardAP
1994-06-29Labeling · Supplement 5 · standardAP
1991-08-02Labeling · Supplement 4AP
1990-11-16Manufacturing (CMC) · Supplement 2 · standardAP
1990-11-09Manufacturing (CMC) · Supplement 1 · standardAP
1990-06-01Manufacturing (CMC) · Supplement 3 · standardAP
1989-12-29Type 3 - New Dosage Form · Original · standardAP
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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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