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FDA NDA · NDA019953

HEPARIN SODIUM IN SODIUM CHLORIDE

Sponsor: B BRAUN

APPLICATION
NDA019953
TYPE
NDA
ORIGINAL APPROVAL
1992-07-20
LATEST ACTION
2025-03-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 10,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 200 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 200 UNITS/100ML · INJECTABLE · INJECTION

Approval history

2025-03-25Labeling · Supplement 48 · standard — Label ↗AP
2023-12-15Labeling · Supplement 44 · standard — Label ↗AP
2016-05-12Labeling · Supplement 32 · standard — Label ↗AP
2014-08-22Manufacturing (CMC) · Supplement 20 · standardAP
2013-08-30Labeling · Supplement 30 · standard — Letter ↗AP
2013-01-10Labeling · Supplement 29 · standard — Letter ↗AP
2011-12-27Labeling · Supplement 25 · standard — Letter ↗AP
2009-02-26Labeling · Supplement 21 · standard — Letter ↗AP
2004-04-13Labeling · Supplement 12 · standard — Letter ↗AP
2002-07-12Manufacturing (CMC) · Supplement 11 · standardAP
2002-02-15Manufacturing (CMC) · Supplement 9 · standardAP
2000-11-22Manufacturing (CMC) · Supplement 8 · standardAP
2000-03-01Manufacturing (CMC) · Supplement 7 · standardAP
1998-06-05Manufacturing (CMC) · Supplement 6 · standardAP
1996-07-30Manufacturing (CMC) · Supplement 5 · standardAP
1995-03-09Manufacturing (CMC) · Supplement 4 · standardAP
1993-03-29Manufacturing (CMC) · Supplement 1 · standardAP
1992-12-22Labeling · Supplement 3 · standardAP
1992-12-02Manufacturing (CMC) · 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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