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FDA NDA · NDA017651

HEPARIN SODIUM

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA017651
TYPE
NDA
ORIGINAL APPROVAL
1978-02-10
LATEST ACTION
2024-10-24
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 20,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferencePrescription
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION

Approval history

2024-10-24Labeling · Supplement 78 · standard — Label ↗AP
2021-06-07Labeling · Supplement 69 · standard — Letter ↗AP
2020-07-02Labeling · Supplement 66 · standard — Letter ↗AP
2016-11-15Manufacturing (CMC) · Supplement 62 · standardAP
2015-11-13Manufacturing (CMC) · Supplement 58 · standardAP
2014-03-21Labeling · Supplement 59 · standard — Letter ↗AP
2013-07-18Manufacturing (CMC) · Supplement 60 · standardAP
2013-03-20Manufacturing (CMC) · Supplement 57 · standardAP
2013-02-16Manufacturing (CMC) · Supplement 56 · standardAP
2011-12-23Labeling · Supplement 55 · standard — Letter ↗AP
2011-06-24Labeling · Supplement 52 · standard — Letter ↗AP
2010-06-11Labeling · Supplement 48 · unknown — Label ↗AP
2009-04-01Labeling · Supplement 46 · standard — Letter ↗AP
2007-12-14Labeling · Supplement 42 · standard — Letter ↗AP
2003-01-07Manufacturing (CMC) · Supplement 35 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 33 · standardAP
1997-12-22Manufacturing (CMC) · Supplement 32 · standardAP
1996-07-26Manufacturing (CMC) · Supplement 26 · standardAP
1995-07-12Manufacturing (CMC) · Supplement 29 · standardAP
1993-08-25Labeling · Supplement 25AP
1992-12-22Labeling · Supplement 31 · standardAP
1992-07-31Labeling · Supplement 30AP
1989-02-09Labeling · Supplement 23AP
1988-10-19Labeling · Supplement 22AP
1985-07-29Labeling · Supplement 20AP
1985-01-08Manufacturing (CMC) · Supplement 21 · standardAP
1984-10-04Labeling · Supplement 18AP
1984-09-19Manufacturing (CMC) · Supplement 19 · standardAP
1984-06-26Efficacy · Supplement 16AP
1983-12-19Efficacy · Supplement 15AP
1983-01-12Manufacturing (CMC) · Supplement 14 · standardAP
1982-04-06Manufacturing (CMC) · Supplement 13 · standardAP
1981-06-02Manufacturing (CMC) · Supplement 12 · standardAP
1980-01-25Labeling · Supplement 8AP
1980-01-21Labeling · Supplement 11AP
1979-10-18Manufacturing (CMC) · Supplement 10 · standardAP
1979-10-03Manufacturing (CMC) · Supplement 5 · standardAP
1979-09-18Manufacturing (CMC) · Supplement 9 · standardAP
1979-07-13Manufacturing (CMC) · Supplement 3 · standardAP
1979-05-29Manufacturing (CMC) · Supplement 7 · 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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