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FDA NDA · NDA019952

HEPARIN SODIUM IN DEXTROSE

heparin sodium and dextrose

Sponsor: B BRAUN

APPLICATION
NDA019952
TYPE
NDA
ORIGINAL APPROVAL
1992-07-20
LATEST ACTION
2023-07-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 10,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 4,000 UNITS/100ML · INJECTABLE · INJECTION

Approval history

2023-07-12Labeling · Supplement 48 · standard — Letter ↗AP
2018-11-03Labeling · Supplement 38 · standard — Letter ↗AP
2016-11-17Manufacturing (CMC) · Supplement 34 · standardAP
2016-05-26Labeling · Supplement 33 · standard — Label ↗AP
2014-08-22Manufacturing (CMC) · Supplement 20 · standardAP
2013-08-30Labeling · Supplement 31 · standard — Letter ↗AP
2013-01-09Labeling · Supplement 30 · unknown — Letter ↗AP
2011-12-23Labeling · Supplement 26 · standard — Letter ↗AP
2009-02-26Labeling · Supplement 21 · standard — Label ↗AP
2004-04-13Labeling · Supplement 12 · standard — Letter ↗AP
2002-07-12Manufacturing (CMC) · Supplement 10 · standardAP
2002-02-15Manufacturing (CMC) · Supplement 8 · standardAP
2000-11-22Manufacturing (CMC) · Supplement 7 · standardAP
2000-03-01Manufacturing (CMC) · Supplement 6 · standardAP
1998-06-05Manufacturing (CMC) · Supplement 5 · standardAP
1996-07-30Manufacturing (CMC) · Supplement 4 · standardAP
1994-12-08Manufacturing (CMC) · Supplement 3 · standardAP
1993-03-29Manufacturing (CMC) · Supplement 1 · standardAP
1992-12-22Labeling · Supplement 2 · standardAP
1992-07-20Type 5 - New Formulation or New Manufacturer · 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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