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FDA NDA · NDA019339

HEPARIN SODIUM AND DEXTROSE

heparin sodium

Sponsor: HOSPIRA

APPLICATION
NDA019339
TYPE
NDA
ORIGINAL APPROVAL
1985-03-27
LATEST ACTION
2024-02-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
HEPARIN SODIUM 10,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
HEPARIN SODIUM 10,000 UNITS/100ML · INJECTABLE · INJECTION

Approval history

2024-02-07Labeling · Supplement 68 · standard — Label ↗AP
2019-09-04Labeling · Supplement 52 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 62 · standard — Letter ↗AP
2014-03-13Labeling · Supplement 54 · standard — Label ↗AP
2013-02-08Manufacturing (CMC) · Supplement 50 · standardAP
2011-12-23Labeling · Supplement 47 · standard — Letter ↗AP
2009-07-23Labeling · Supplement 38 · standard — Letter ↗AP
2008-10-17Labeling · Supplement 34 · standard — Letter ↗AP
2002-11-07Manufacturing (CMC) · Supplement 25 · standardAP
1999-11-19Labeling · Supplement 24 · standardAP
1998-10-27Manufacturing (CMC) · Supplement 22 · standardAP
1998-10-27Manufacturing (CMC) · Supplement 23 · standardAP
1998-05-27Labeling · Supplement 19 · standardAP
1998-03-16Labeling · Supplement 21 · standardAP
1997-06-09Manufacturing (CMC) · Supplement 20 · standardAP
1996-08-30Manufacturing (CMC) · Supplement 16 · standardAP
1996-02-07Manufacturing (CMC) · Supplement 18 · standardAP
1995-08-24Manufacturing (CMC) · Supplement 17 · standardAP
1995-08-22Manufacturing (CMC) · Supplement 15 · standardAP
1994-11-10Manufacturing (CMC) · Supplement 14 · standardAP
1994-11-10Manufacturing (CMC) · Supplement 12 · standardAP
1994-11-10Manufacturing (CMC) · Supplement 13 · standardAP
1994-11-10Manufacturing (CMC) · Supplement 11 · standardAP
1992-02-25Manufacturing (CMC) · Supplement 9 · standardAP
1992-02-18Manufacturing (CMC) · Supplement 8 · standardAP
1990-02-16Manufacturing (CMC) · Supplement 6 · standardAP
1986-10-29Manufacturing (CMC) · Supplement 4 · standardAP
1986-09-24Manufacturing (CMC) · Supplement 2 · standardAP
1986-08-03Manufacturing (CMC) · Supplement 3 · standardAP
1986-04-01Manufacturing (CMC) · Supplement 1 · standardAP
1985-03-27Type 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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