← FDA DRUG APPROVALS

FDA NDA · NDA018916

HEPARIN SODIUM

Sponsor: HOSPIRA

APPLICATION
NDA018916
TYPE
NDA
ORIGINAL APPROVAL
1984-01-31
LATEST ACTION
2025-11-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 5,000 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 10,000 UNITS IN SODIUM CHLORIDE 0.45%Discontinued
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 12,500 UNITS IN SODIUM CHLORIDE 0.9%Discontinued
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%Discontinued
HEPARIN SODIUM 1,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 10,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%Discontinued
HEPARIN SODIUM 100 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
HEPARIN SODIUM 200 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%Discontinued
HEPARIN SODIUM 10,000 UNITS/100ML · INJECTABLE · INJECTION

Approval history

2025-11-19Labeling · Supplement 83 · standard — Letter ↗AP
2024-12-10Labeling · Supplement 80 · standard — Letter ↗AP
2024-10-24Labeling · Supplement 79 · standard — Label ↗AP
2020-07-30Labeling · Supplement 71 · standard — Letter ↗AP
2019-09-04Labeling · Supplement 63 · standard — Letter ↗AP
2016-07-18Manufacturing (CMC) · Supplement 70 · standardAP
2016-04-05Labeling · Supplement 69 · standard — Letter ↗AP
2016-04-05Labeling · Supplement 66 · standard — Letter ↗AP
2015-04-14Manufacturing (CMC) · Supplement 68 · standardAP
2015-03-03Manufacturing (CMC) · Supplement 67 · standardAP
2014-01-15Manufacturing (CMC) · Supplement 64 · standardAP
2013-07-15Manufacturing (CMC) · Supplement 62 · standardAP
2013-02-12Labeling · Supplement 60 · standard — Letter ↗AP
2013-02-08Manufacturing (CMC) · Supplement 61 · standardAP
2012-11-30Manufacturing (CMC) · Supplement 59 · standardAP
2011-12-23Labeling · Supplement 57 · standard — Label ↗AP
1999-11-19Labeling · Supplement 33 · standardAP
1998-10-27Manufacturing (CMC) · Supplement 32 · standardAP
1998-08-25Labeling · Supplement 28 · standardAP
1997-08-29Manufacturing (CMC) · Supplement 31 · standardAP
1997-06-25Manufacturing (CMC) · Supplement 30 · standardAP
1997-06-09Manufacturing (CMC) · Supplement 29 · standardAP
1997-04-03Manufacturing (CMC) · Supplement 27 · standardAP
1996-09-05Manufacturing (CMC) · Supplement 24 · standardAP
1996-08-30Manufacturing (CMC) · Supplement 23 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 26 · standardAP
1996-02-07Manufacturing (CMC) · Supplement 25 · standardAP
1992-02-25Manufacturing (CMC) · Supplement 20 · standardAP
1992-02-18Manufacturing (CMC) · Supplement 18 · standardAP
1991-10-02Labeling · Supplement 21AP
1990-10-29Manufacturing (CMC) · Supplement 16 · standardAP
1990-02-16Manufacturing (CMC) · Supplement 15 · standardAP
1989-06-23Efficacy · Supplement 8AP
1988-10-24Labeling · Supplement 12AP
1987-08-21Manufacturing (CMC) · Supplement 7 · standardAP
1986-10-29Manufacturing (CMC) · Supplement 6 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 5 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 4 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 3 · standardAP
1985-04-16Manufacturing (CMC) · Supplement 2 · 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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