APPLICATION
ANDA090809
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-30
LATEST ACTION
2022-01-12
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HEPARIN SODIUMPrescription
HEPARIN SODIUM 20,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2022-01-12Labeling · Supplement 10 · standardAP
2022-01-12Labeling · Supplement 8 · standardAP
2014-02-21Labeling · Supplement 5 · standardAP
2013-04-29Labeling · Supplement 3AP
2013-04-29Labeling · Supplement 4 · standardAP
2010-06-30OriginalAP
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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