← FDA DRUG APPROVALS

FDA NDA · NDA019042

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA019042
TYPE
NDA
ORIGINAL APPROVAL
1985-03-29
LATEST ACTION
1992-04-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 1,000 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 200 UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

1992-04-20Manufacturing (CMC) · Supplement 6 · standardAP
1990-03-30Manufacturing (CMC) · Supplement 5 · standardAP
1989-06-21Labeling · Supplement 4 · standardAP
1987-04-17Manufacturing (CMC) · Supplement 2 · standardAP
1985-09-10Manufacturing (CMC) · Supplement 1 · standardAP
1985-03-29Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →