APPLICATION
NDA005521
TYPE
NDA
ORIGINAL APPROVAL
1944-05-19
LATEST ACTION
2000-05-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 20,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2000-05-23Manufacturing (CMC) · Supplement 26AP
1999-04-27Manufacturing (CMC) · Supplement 19AP
1998-06-05Manufacturing (CMC) · Supplement 24AP
1996-01-31Manufacturing (CMC) · Supplement 23AP
1989-11-29Labeling · Supplement 21AP
1989-10-27Labeling · Supplement 20AP
1989-06-01Labeling · Supplement 17AP
1989-06-01Labeling · Supplement 18AP
1985-05-13Labeling · Supplement 16AP
1982-07-08Manufacturing (CMC) · Supplement 11AP
1981-06-16Manufacturing (CMC) · Supplement 15AP
1981-03-19Manufacturing (CMC) · Supplement 14AP
1980-01-17Labeling · Supplement 12AP
1979-09-07Manufacturing (CMC) · Supplement 13AP
1976-03-18Manufacturing (CMC) · Supplement 8AP
1944-05-19OriginalAP
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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