← FDA DRUG APPROVALS

FDA NDA · NDA018609

HEPARIN SODIUM IN SODIUM CHLORIDE

heparin sodium

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA018609
TYPE
NDA
ORIGINAL APPROVAL
1982-04-28
LATEST ACTION
2022-01-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
HEPARIN SODIUM 2,000 UNITS/1000ML · INJECTABLE · INJECTION
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
HEPARIN SODIUM 200 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
HEPARIN SODIUM 500 UNITS/100ML · INJECTABLE · INJECTION
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
HEPARIN SODIUM 200 UNITS/100ML · INJECTABLE · INJECTION

Approval history

2022-01-03Labeling · Supplement 58 · standard — Letter ↗AP
2019-07-15Labeling · Supplement 54 · standard — Letter ↗AP
2016-07-25Manufacturing (CMC) · Supplement 50 · standardAP
2015-08-18Manufacturing (CMC) · Supplement 49 · standardAP
2012-02-27Labeling · Supplement 42 · standard — Letter ↗AP
2010-08-13Labeling · Supplement 44 · unknown — Letter ↗AP
2001-08-21Labeling · Supplement 35 · standard — Review ↗AP
2001-08-21Labeling · Supplement 33 · standard — Review ↗AP
2001-08-14Manufacturing (CMC) · Supplement 37 · standardAP
1999-11-23Manufacturing (CMC) · Supplement 36 · standardAP
1999-06-01Manufacturing (CMC) · Supplement 34 · standardAP
1997-05-20Manufacturing (CMC) · Supplement 32 · standardAP
1996-09-17Labeling · Supplement 31 · standardAP
1994-09-14Manufacturing (CMC) · Supplement 29 · standardAP
1994-03-10Manufacturing (CMC) · Supplement 30 · standardAP
1993-04-15Manufacturing (CMC) · Supplement 27 · standardAP
1991-03-04Manufacturing (CMC) · Supplement 25 · standardAP
1991-02-01Manufacturing (CMC) · Supplement 23 · standardAP
1990-07-26Manufacturing (CMC) · Supplement 24 · standardAP
1989-11-08Labeling · Supplement 15AP
1989-11-08Labeling · Supplement 21AP
1989-11-08Labeling · Supplement 10AP
1989-08-24Manufacturing (CMC) · Supplement 22 · standardAP
1987-04-29Manufacturing (CMC) · Supplement 20 · standardAP
1986-12-01Manufacturing (CMC) · Supplement 19 · standardAP
1986-12-01Manufacturing (CMC) · Supplement 18 · standardAP
1985-09-20Manufacturing (CMC) · Supplement 17 · standardAP
1985-09-20Manufacturing (CMC) · Supplement 16 · standardAP
1984-10-16Manufacturing (CMC) · Supplement 14 · standardAP
1984-08-03Manufacturing (CMC) · Supplement 13 · standardAP
1984-03-06Manufacturing (CMC) · Supplement 8 · standardAP
1984-03-06Manufacturing (CMC) · Supplement 4 · standardAP
1984-03-06Labeling · Supplement 11AP
1984-03-06Manufacturing (CMC) · Supplement 9 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 12 · standardAP
1982-08-09Manufacturing (CMC) · Supplement 2 · standardAP
1982-08-09Manufacturing (CMC) · Supplement 3 · standardAP
1982-06-29Manufacturing (CMC) · Supplement 1 · standardAP
1982-04-28Type 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 →