APPLICATION
ANDA077857
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-23
LATEST ACTION
2024-06-14
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 120MG/0.8ML (150MG/ML) · INJECTABLE · SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 60MG/0.6ML (100MG/ML) · INJECTABLE · SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 30MG/0.3ML (100MG/ML) · INJECTABLE · SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 150MG/ML (150MG/ML) · INJECTABLE · SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 80MG/0.8ML (100MG/ML) · INJECTABLE · SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 40MG/0.4ML (100MG/ML) · INJECTABLE · SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 100MG/ML (100MG/ML) · INJECTABLE · SUBCUTANEOUS
Approval history
2024-06-14Labeling · Supplement 45 · standardAP
2022-12-09Labeling · Supplement 41 · standardAP
2020-06-18Labeling · Supplement 35 · standardAP
2015-12-28Labeling · Supplement 20 · standardAP
2013-10-29Labeling · Supplement 18 · standardAP
2011-11-22Labeling · Supplement 4AP
2011-10-31Labeling · Supplement 8AP
2011-07-25Labeling · Supplement 5AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.