← FDA DRUG APPROVALS

FDA NDA · NDA019802

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA019802
TYPE
NDA
ORIGINAL APPROVAL
1992-07-20
LATEST ACTION
2014-08-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 10,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 5,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2014-08-22Manufacturing (CMC) · Supplement 16 · standardAP
2002-07-12Manufacturing (CMC) · Supplement 9 · standardAP
2002-02-15Manufacturing (CMC) · Supplement 7 · standardAP
2000-11-22Manufacturing (CMC) · Supplement 6 · standardAP
1998-06-05Manufacturing (CMC) · Supplement 5 · standardAP
1993-03-29Manufacturing (CMC) · Supplement 1 · standardAP
1992-12-22Labeling · Supplement 3 · standardAP
1992-12-02Manufacturing (CMC) · Supplement 2 · standardAP
1992-07-20Type 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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