APPLICATION
NDA017064
TYPE
NDA
ORIGINAL APPROVAL
1974-11-22
LATEST ACTION
2024-10-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 7,500 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 4,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 2,500 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 20,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN LOCK FLUSHDiscontinued
HEPARIN SODIUM 100 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 6,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 3,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 40,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
1999-01-27Manufacturing (CMC) · Supplement 58 · standardAP
1998-05-01Manufacturing (CMC) · Supplement 57 · standardAP
1996-11-25Manufacturing (CMC) · Supplement 56 · standardAP
1994-06-29Manufacturing (CMC) · Supplement 55 · standardAP
1993-11-08Manufacturing (CMC) · Supplement 54 · standardAP
1993-08-11Manufacturing (CMC) · Supplement 51 · standardAP
1992-07-28Manufacturing (CMC) · Supplement 53 · standardAP
1992-07-28Manufacturing (CMC) · Supplement 52 · standardAP
1991-10-18Manufacturing (CMC) · Supplement 48 · standardAP
1991-07-10Labeling · Supplement 50AP
1991-04-23Labeling · Supplement 49AP
1991-04-03Manufacturing (CMC) · Supplement 47 · standardAP
1990-02-16Manufacturing (CMC) · Supplement 46 · standardAP
1990-01-17Labeling · Supplement 45AP
1989-06-14Manufacturing (CMC) · Supplement 39 · standardAP
1989-06-14Manufacturing (CMC) · Supplement 43 · standardAP
1989-06-14Manufacturing (CMC) · Supplement 41 · standardAP
1989-06-14Manufacturing (CMC) · Supplement 44 · standardAP
1989-06-14Manufacturing (CMC) · Supplement 40 · standardAP
1989-04-28Labeling · Supplement 42AP
1987-11-19Labeling · Supplement 38AP
1987-09-14Labeling · Supplement 37AP
1987-05-22Manufacturing (CMC) · Supplement 36 · standardAP
1986-12-19Labeling · Supplement 35AP
1986-04-07Manufacturing (CMC) · Supplement 34 · standardAP
1986-01-14Manufacturing (CMC) · Supplement 33 · standardAP
1985-10-04Labeling · Supplement 32AP
1981-05-26Manufacturing (CMC) · Supplement 31 · standardAP
1981-03-02Labeling · Supplement 30AP
1978-07-07Manufacturing (CMC) · Supplement 29 · standardAP
1978-07-07Manufacturing (CMC) · Supplement 27 · standardAP
1978-07-07Labeling · Supplement 28AP
1978-06-02Labeling · Supplement 25AP
1978-06-02Labeling · Supplement 26AP
1978-04-14Manufacturing (CMC) · Supplement 24 · standardAP
1977-09-13Manufacturing (CMC) · Supplement 23 · standardAP
1977-06-29REMS · Supplement 21 · standardAP
1977-06-29Manufacturing (CMC) · Supplement 22 · standardAP
1977-02-24Manufacturing (CMC) · Supplement 19 · standardAP
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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