APPLICATION
NDA017007
TYPE
NDA
ORIGINAL APPROVAL
1974-05-28
LATEST ACTION
2024-10-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN LOCK FLUSHDiscontinued
HEPARIN SODIUM 10 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN LOCK FLUSHDiscontinued
HEPARIN SODIUM 100 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1997-03-05Labeling · Supplement 36 · standardAP
1996-05-20Manufacturing (CMC) · Supplement 35 · priorityAP
1993-10-20Manufacturing (CMC) · Supplement 33 · priorityAP
1993-06-14Manufacturing (CMC) · Supplement 32 · priorityAP
1991-02-28Manufacturing (CMC) · Supplement 25 · priorityAP
1990-07-20Labeling · Supplement 31AP
1989-07-13Labeling · Supplement 29AP
1989-06-29Labeling · Supplement 28AP
1987-07-29Manufacturing (CMC) · Supplement 24 · priorityAP
1987-04-14Manufacturing (CMC) · Supplement 23 · priorityAP
1987-03-05Labeling · Supplement 22AP
1986-04-07Labeling · Supplement 15AP
1983-10-19Labeling · Supplement 19AP
1983-08-29Labeling · Supplement 18AP
1983-05-25Manufacturing (CMC) · Supplement 17 · priorityAP
1982-07-30Manufacturing (CMC) · Supplement 16 · priorityAP
1981-05-14Manufacturing (CMC) · Supplement 14 · priorityAP
1980-07-02Manufacturing (CMC) · Supplement 13 · priorityAP
1980-07-02Manufacturing (CMC) · Supplement 12 · priorityAP
1978-10-04Labeling · Supplement 11AP
1978-07-03Manufacturing (CMC) · Supplement 9 · priorityAP
1978-07-03Labeling · Supplement 10AP
1978-02-02Manufacturing (CMC) · Supplement 8 · priorityAP
1978-02-02Manufacturing (CMC) · Supplement 7 · priorityAP
1976-12-29Manufacturing (CMC) · Supplement 6 · priorityAP
1975-12-12Manufacturing (CMC) · Supplement 4 · priorityAP
1975-10-17Manufacturing (CMC) · Supplement 5 · priorityAP
1975-03-28Manufacturing (CMC) · Supplement 3 · priorityAP
1974-05-28Type 3 - New Dosage Form · Original · priorityAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.