← FDA DRUG APPROVALS

FDA ANDA · ANDA214646

ENOXAPARIN SODIUM

Sponsor: BE PHARMS

APPLICATION
ANDA214646
TYPE
ANDA
ORIGINAL APPROVAL
2023-06-06
LATEST ACTION
2023-06-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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
ENOXAPARIN SODIUM (PRESERVATIVE FREE)Prescription
ENOXAPARIN SODIUM 120MG/0.8ML (150MG/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2023-06-06UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →