APPLICATION
ANDA211005
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-14
LATEST ACTION
2026-02-20
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HEPARIN SODIUMPrescription
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2026-02-20Labeling · Supplement 8 · standardAP
2021-10-25Labeling · Supplement 4 · standardAP
2020-09-29Labeling · Supplement 3 · standardAP
2018-12-14UNKNOWN · Original · 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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