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FDA ANDA · ANDA076726

ENOXAPARIN SODIUM

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA076726
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-23
LATEST ACTION
2022-09-12
ROUTE
INTRAVENOUS, 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 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 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

Approval history

2022-09-12Labeling · Supplement 12 · standardAP
2020-03-19Labeling · Supplement 9 · standardAP
2016-01-12Labeling · Supplement 3 · standardAP
2014-06-23OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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