APPLICATION
NDA004570
TYPE
NDA
ORIGINAL APPROVAL
1942-02-05
LATEST ACTION
2000-04-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMDiscontinued
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2000-04-03Manufacturing (CMC) · Supplement 56AP
1999-09-15Labeling · Supplement 55 · standardAP
1996-03-04Labeling · Supplement 54 · standardAP
1996-01-31Manufacturing (CMC) · Supplement 53AP
1991-07-09Manufacturing (CMC) · Supplement 52AP
1990-01-29Manufacturing (CMC) · Supplement 49AP
1988-11-16Labeling · Supplement 51AP
1988-08-12Labeling · Supplement 50AP
1988-01-29Manufacturing (CMC) · Supplement 46AP
1987-07-24Labeling · Supplement 48AP
1987-01-21Labeling · Supplement 47AP
1986-10-24Labeling · Supplement 43AP
1983-03-25Labeling · Supplement 45AP
1983-01-21Labeling · Supplement 44AP
1981-08-19Labeling · Supplement 42AP
1981-06-02Labeling · Supplement 41AP
1981-06-02Labeling · Supplement 33AP
1981-02-18Labeling · Supplement 35AP
1981-02-04Labeling · Supplement 40AP
1981-01-14Labeling · Supplement 39AP
1980-12-03Manufacturing (CMC) · Supplement 38AP
1980-10-14Manufacturing (CMC) · Supplement 36AP
1980-08-20Manufacturing (CMC) · Supplement 37AP
1980-02-05Manufacturing (CMC) · Supplement 32AP
1980-02-05Manufacturing (CMC) · Supplement 31AP
1980-02-05Manufacturing (CMC) · Supplement 34AP
1978-10-04Manufacturing (CMC) · Supplement 29AP
1978-02-02Manufacturing (CMC) · Supplement 26AP
1977-02-11Manufacturing (CMC) · Supplement 23AP
1976-07-09Manufacturing (CMC) · Supplement 20AP
1976-02-24Labeling · Supplement 22AP
1976-02-24Labeling · Supplement 21AP
1975-08-14Manufacturing (CMC) · Supplement 18AP
1975-08-14Labeling · Supplement 19AP
1942-02-05UNKNOWN · 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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