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FDA NDA · NDA018911

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%

Sponsor: HOSPIRA

APPLICATION
NDA018911
TYPE
NDA
ORIGINAL APPROVAL
1985-01-30
LATEST ACTION
1999-08-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%Discontinued
HEPARIN SODIUM 10,000 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 25,000 UNITS IN DEXTROSE 5%Discontinued
HEPARIN SODIUM 10,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%Discontinued
HEPARIN SODIUM 10,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%Discontinued
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 25,000 UNITS IN DEXTROSE 5%Discontinued
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5%Discontinued
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%Discontinued
HEPARIN SODIUM 5,000 UNITS/100ML · INJECTABLE · INJECTION

Approval history

1999-08-24Labeling · Supplement 10 · standardAP
1998-05-27Labeling · Supplement 9 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 7 · standardAP
1995-08-24Manufacturing (CMC) · Supplement 8 · standardAP
1992-02-25Manufacturing (CMC) · Supplement 6 · standardAP
1991-07-24Labeling · Supplement 5 · standardAP
1987-09-14Labeling · Supplement 3 · standardAP
1986-09-24Manufacturing (CMC) · Supplement 2 · standardAP
1985-07-29Labeling · Supplement 1 · standardAP
1985-01-30Type 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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