APPLICATION
ANDA090571
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-31
LATEST ACTION
2026-07-13
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HEPARIN SODIUMPrescription
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMPrescription
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMPrescription
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2026-07-13Labeling · Supplement 38 · standardAP
2020-07-15Labeling · Supplement 20 · standardAP
2014-02-24Labeling · Supplement 13 · standardAP
2013-05-23Labeling · Supplement 7 · standardAP
2013-05-06Labeling · Supplement 11 · standardAP
2010-01-27Labeling · Supplement 4AP
2009-08-31OriginalAP
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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