APPLICATION
ANDA078660
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-28
LATEST ACTION
2023-01-05
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ENOXAPARIN SODIUMPrescription
ENOXAPARIN SODIUM 300MG/3ML (100MG/ML) · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
Approval history
2023-01-05Labeling · Supplement 19 · standardAP
2015-12-28Labeling · Supplement 12 · standardAP
2013-10-29Labeling · Supplement 11 · standardAP
2013-01-31Labeling · Supplement 2AP
2011-11-28OriginalAP
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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