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FDA NDA · NDA018814
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA018814
TYPE
NDA
ORIGINAL APPROVAL
1983-10-31
LATEST ACTION
2010-08-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 10,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 2,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 4,000 UNITS/100ML · INJECTABLE · INJECTION
Approval history
2000-10-19Labeling · Supplement 26 · standardAP
2000-02-04Labeling · Supplement 24 · standardAP
1999-11-23Manufacturing (CMC) · Supplement 27 · standardAP
1999-06-01Manufacturing (CMC) · Supplement 25 · standardAP
1996-09-17Labeling · Supplement 22 · standardAP
1994-09-14Manufacturing (CMC) · Supplement 20 · standardAP
1994-07-20Manufacturing (CMC) · Supplement 19 · standardAP
1994-07-20Manufacturing (CMC) · Supplement 18 · standardAP
1994-03-10Manufacturing (CMC) · Supplement 21 · standardAP
1993-04-15Manufacturing (CMC) · Supplement 17 · standardAP
1992-11-19Labeling · Supplement 13 · standardAP
1991-07-16Manufacturing (CMC) · Supplement 15 · standardAP
1991-04-25Manufacturing (CMC) · Supplement 11 · standardAP
1991-03-04Manufacturing (CMC) · Supplement 12 · standardAP
1989-08-24Manufacturing (CMC) · Supplement 10 · standardAP
1988-02-19Labeling · Supplement 9 · standardAP
1987-07-08Manufacturing (CMC) · Supplement 8 · standardAP
1985-10-08Manufacturing (CMC) · Supplement 7 · standardAP
1985-07-09Efficacy · Supplement 6 · standardAP
1985-06-17Manufacturing (CMC) · Supplement 5 · standardAP
1985-01-31Labeling · Supplement 4 · standardAP
1984-10-16Manufacturing (CMC) · Supplement 2 · standardAP
1984-06-08Manufacturing (CMC) · Supplement 1 · standardAP
1983-10-31Type 5 - New Formulation or New Manufacturer · Original · 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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