APPLICATION
NDA000552
TYPE
NDA
ORIGINAL APPROVAL
1939-02-09
LATEST ACTION
2024-10-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
LIQUAEMIN SODIUM PRESERVATIVE FREEDiscontinued
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
LIQUAEMIN SODIUMDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
LIQUAEMIN SODIUMDiscontinued
HEPARIN SODIUM 40,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
LIQUAEMIN LOCK FLUSHDiscontinued
HEPARIN SODIUM 100 UNITS/ML · INJECTABLE · INJECTION
LIQUAEMIN SODIUM PRESERVATIVE FREEDiscontinued
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
LIQUAEMIN SODIUMDiscontinued
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
LIQUAEMIN SODIUM PRESERVATIVE FREEDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
LIQUAEMIN SODIUMDiscontinued
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
LIQUAEMIN SODIUMDiscontinued
HEPARIN SODIUM 20,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
1990-08-02Manufacturing (CMC) · Supplement 24AP
1988-08-05Labeling · Supplement 23AP
1987-12-09Manufacturing (CMC) · Supplement 22AP
1987-01-06Manufacturing (CMC) · Supplement 21AP
1986-07-28Manufacturing (CMC) · Supplement 20AP
1986-04-11Efficacy · Supplement 18AP
1985-05-13Labeling · Supplement 17AP
1981-06-08Manufacturing (CMC) · Supplement 11AP
1981-03-24Labeling · Supplement 13AP
1980-11-28Manufacturing (CMC) · Supplement 14AP
1980-11-28Manufacturing (CMC) · Supplement 15AP
1978-05-15Manufacturing (CMC) · Supplement 10AP
1978-01-25Labeling · Supplement 12AP
1975-07-28REMS · Supplement 7AP
1975-07-28REMS · Supplement 8AP
1939-02-09UNKNOWN · Original · unknownAP
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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