APPLICATION
ANDA078990
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-28
LATEST ACTION
2024-06-26
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 40MG/0.4ML (100MG/ML) · INJECTABLE · SUBCUTANEOUS
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
Approval history
2024-06-26Labeling · Supplement 16 · standardAP
2024-06-26Labeling · Supplement 19 · standardAP
2022-07-28Labeling · Supplement 12 · standardAP
2020-03-19Labeling · Supplement 3 · standardAP
2018-09-28OriginalAP
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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