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FDA NDA · NDA019134
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA019134
TYPE
NDA
ORIGINAL APPROVAL
1985-03-29
LATEST ACTION
1992-04-20
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
Approval history
1992-04-20Manufacturing (CMC) · Supplement 8 · standardAP
1990-03-30Manufacturing (CMC) · Supplement 7 · standardAP
1988-11-22Labeling · Supplement 6 · standardAP
1987-12-29Labeling · Supplement 4 · standardAP
1987-08-04Labeling · Supplement 3 · standardAP
1986-10-21Manufacturing (CMC) · Supplement 2 · standardAP
1985-09-10Labeling · Supplement 1 · standardAP
1985-03-29Type 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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