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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 218775

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NDA 218775 describes ENOXAPARIN SODIUM (PRESERVATIVE FREE), which is a drug marketed by Amphastar Pharm, Be Pharms, Emerge Bioscience, Gland, Hebei Changshan, Sandoz, Shenzhen Techdow, and Zydus Pharms, and is included in eight NDAs. It is available from fifteen suppliers. Additional details are available on the ENOXAPARIN SODIUM (PRESERVATIVE FREE) profile page.

The generic ingredient in ENOXAPARIN SODIUM (PRESERVATIVE FREE) is enoxaparin sodium. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.

Summary for 218775

Tradename:	ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Applicant:	Hebei Changshan
Ingredient:	enoxaparin sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 218775

Anticoagulants
Fibrinolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	30MG/0.3ML (100MG/ML)
Approval Date:	Jan 7, 2026	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	40MG/0.4ML (100MG/ML)
Approval Date:	Jan 7, 2026	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	60MG/0.6ML (100MG/ML)
Approval Date:	Jan 7, 2026	TE:	AP	RLD:	No

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