APPLICATION
ANDA205323
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-06
LATEST ACTION
2025-04-09
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HEPARIN SODIUMPrescription
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUMPrescription
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2025-04-09Labeling · Supplement 10 · standardAP
2019-11-20Labeling · Supplement 1 · 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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