APPLICATION
ANDA076684
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-19
LATEST ACTION
2022-11-15
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 150MG/ML (150MG/ML) · INJECTABLE · SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 100MG/ML (100MG/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 120MG/0.8ML (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
Approval history
2022-11-15Labeling · Supplement 16 · standardAP
2020-10-30Labeling · Supplement 11 · standardAP
2014-10-24Manufacturing (CMC) · Supplement 3AP
2012-08-24Labeling · Supplement 4 · 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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