← FDA DRUG APPROVALS

FDA NDA · NDA017029

HEPARIN SODIUM

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA017029
TYPE
NDA
ORIGINAL APPROVAL
1972-02-22
LATEST ACTION
2024-10-24
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% · ReferencePrescription
HEPARIN SODIUM 50 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 20,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% · ReferencePrescription
HEPARIN SODIUM 50 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferencePrescription
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferencePrescription
HEPARIN SODIUM 20,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM PRESERVATIVE FREE · ReferencePrescription
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM PRESERVATIVE FREE · ReferencePrescription
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% · ReferencePrescription
HEPARIN SODIUM 100 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% · ReferencePrescription
HEPARIN SODIUM 100 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% · ReferenceDiscontinued
HEPARIN SODIUM 40 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferencePrescription
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferencePrescription
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION

Approval history

2024-10-24Labeling · Supplement 178 · standard — Label ↗AP
2021-06-07Labeling · Supplement 159 · standard — Letter ↗AP
2020-07-02Labeling · Supplement 156 · standard — Letter ↗AP
2018-11-16Labeling · Supplement 141 · standard — Label ↗AP
2017-08-24Labeling · Supplement 140 · standard — Letter ↗AP
2016-06-09Manufacturing (CMC) · Supplement 139 · standardAP
2015-12-23Manufacturing (CMC) · Supplement 129 · standardAP
2015-07-21Manufacturing (CMC) · Supplement 137 · standardAP
2015-03-09Manufacturing (CMC) · Supplement 134 · standardAP
2014-03-21Labeling · Supplement 135 · unknown — Letter ↗AP
2013-09-24Manufacturing (CMC) · Supplement 136 · standardAP
2011-12-23Labeling · Supplement 131 · unknown — Letter ↗AP
2011-06-24Labeling · Supplement 128 · unknown — Letter ↗AP
2011-03-31Manufacturing (CMC) · Supplement 115AP
2010-06-11Labeling · Supplement 120 · unknown — Letter ↗AP
2008-09-23Labeling · Supplement 108 · standard — Letter ↗AP
2002-03-22Labeling · Supplement 99 · standard — Letter ↗AP
2000-03-08Manufacturing (CMC) · Supplement 97 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 98 · standardAP
1998-08-06Manufacturing (CMC) · Supplement 62 · standardAP
1998-08-06Manufacturing (CMC) · Supplement 63 · standardAP
1998-08-06Manufacturing (CMC) · Supplement 94 · standardAP
1997-11-04Manufacturing (CMC) · Supplement 96 · standardAP
1997-06-24Manufacturing (CMC) · Supplement 95 · standardAP
1996-07-26Manufacturing (CMC) · Supplement 73 · standardAP
1995-05-17Manufacturing (CMC) · Supplement 84 · standardAP
1994-10-27Manufacturing (CMC) · Supplement 78 · standardAP
1993-08-25Labeling · Supplement 69AP
1992-06-26Labeling · Supplement 56AP
1989-12-01Manufacturing (CMC) · Supplement 57 · standardAP
1989-06-08Manufacturing (CMC) · Supplement 61 · standardAP
1988-09-22Labeling · Supplement 60AP
1988-02-16Manufacturing (CMC) · Supplement 58 · standardAP
1987-09-22Manufacturing (CMC) · Supplement 50 · standardAP
1987-09-22Manufacturing (CMC) · Supplement 51 · standardAP
1986-04-28Manufacturing (CMC) · Supplement 54 · standardAP
1986-04-07Labeling · Supplement 53AP
1985-12-05Manufacturing (CMC) · Supplement 46 · standardAP
1985-12-05Manufacturing (CMC) · Supplement 44 · standardAP
1985-12-05Manufacturing (CMC) · Supplement 42 · standardAP
VIEW ON DRUGS@FDA ↗

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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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