APPLICATION
ANDA088100
TYPE
ANDA
ORIGINAL APPROVAL
1983-04-28
LATEST ACTION
2026-07-09
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HEPARIN SODIUMPrescription
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2026-07-09Labeling · Supplement 74 · standardAP
2020-08-13Labeling · Supplement 50 · standardAP
2013-05-20Labeling · Supplement 41 · standardAP
2013-05-06Labeling · Supplement 38 · standardAP
2013-05-01Labeling · Supplement 37 · standardAP
2009-12-30Labeling · Supplement 32AP
2009-05-06Labeling · Supplement 30AP
2008-10-23Labeling · Supplement 27AP
2001-02-14Manufacturing (CMC) · Supplement 14AP
1998-09-09Labeling · Supplement 13AP
1996-12-11Manufacturing (CMC) · Supplement 12AP
1996-12-02Manufacturing (CMC) · Supplement 11AP
1995-12-22Manufacturing (CMC) · Supplement 10AP
1993-12-01Manufacturing (CMC) · Supplement 6AP
1992-09-21Labeling · Supplement 7AP
1992-06-01Manufacturing (CMC) · Supplement 4AP
1992-04-06Manufacturing (CMC) · Supplement 8AP
1991-02-15Labeling · Supplement 5AP
1989-07-11Manufacturing (CMC) · Supplement 3AP
1985-05-08Manufacturing (CMC) · Supplement 2AP
1983-04-28OriginalAP
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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