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FDA NDA · NDA019805
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
NDA019805
TYPE
NDA
ORIGINAL APPROVAL
1989-01-25
LATEST ACTION
2019-09-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 4,000 UNITS/100ML · INJECTABLE · INJECTION
Approval history
2013-02-08Manufacturing (CMC) · Supplement 32 · standardAP
2002-09-18Manufacturing (CMC) · Supplement 15 · standardAP
2000-03-16Labeling · Supplement 14 · standardAP
1998-05-27Labeling · Supplement 12 · standardAP
1997-11-25Manufacturing (CMC) · Supplement 13 · standardAP
1996-09-05Manufacturing (CMC) · Supplement 9 · standardAP
1996-08-30Manufacturing (CMC) · Supplement 8 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 11 · standardAP
1995-08-24Manufacturing (CMC) · Supplement 10 · standardAP
1992-02-25Manufacturing (CMC) · Supplement 7 · standardAP
1992-02-18Manufacturing (CMC) · Supplement 5 · standardAP
1990-10-16Manufacturing (CMC) · Supplement 4 · standardAP
1990-02-16Manufacturing (CMC) · Supplement 3 · standardAP
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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