APPLICATION
ANDA089522
TYPE
ANDA
ORIGINAL APPROVAL
1987-05-04
LATEST ACTION
2026-07-09
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HEPARIN SODIUM PRESERVATIVE FREEPrescription
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2026-07-09Labeling · Supplement 76 · standardAP
2020-08-13Labeling · Supplement 56 · standardAP
2014-05-29Manufacturing (CMC) · Supplement 43AP
2013-05-06Labeling · Supplement 47 · standardAP
2012-11-23Labeling · Supplement 44 · standardAP
2010-01-19Labeling · Supplement 35AP
2010-01-14Labeling · Supplement 36AP
2009-05-08Labeling · Supplement 33AP
2008-10-28Labeling · Supplement 30AP
2001-02-14Manufacturing (CMC) · Supplement 15AP
1998-09-09Labeling · Supplement 14AP
1998-08-10Manufacturing (CMC) · Supplement 13AP
1996-12-11Manufacturing (CMC) · Supplement 12AP
1996-12-02Manufacturing (CMC) · Supplement 11AP
1995-12-22Manufacturing (CMC) · Supplement 10AP
1994-09-09Manufacturing (CMC) · Supplement 9AP
1993-11-22Labeling · Supplement 7AP
1993-11-22Manufacturing (CMC) · Supplement 8AP
1992-09-21Labeling · Supplement 4AP
1992-04-06Manufacturing (CMC) · Supplement 5AP
1991-02-22Labeling · Supplement 3AP
1990-03-14Manufacturing (CMC) · Supplement 2AP
1989-07-06Manufacturing (CMC) · Supplement 1AP
1987-05-04OriginalAP
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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