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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 216958

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NDA 216958 describes CYCLOPHOSPHAMIDE, which is a drug marketed by Alembic, Ani Pharms, Cipla, Eirgen, Hikma, Senores Pharms, Zydus Lifesciences, Amneal, Baxter Hlthcare, Epic Pharma Llc, Hainan Poly, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Nexus, Sandoz, and Roxane, and is included in twenty-six NDAs. It is available from twenty-three suppliers. There are three patents protecting this drug. Additional details are available on the CYCLOPHOSPHAMIDE profile page.

The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.

Summary for 216958

Tradename:	CYCLOPHOSPHAMIDE
Applicant:	Hikma
Ingredient:	cyclophosphamide
Patents:	0

Medical Subject Heading (MeSH) Categories for 216958

Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunosuppressive Agents
Mutagens
Myeloablative Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Dec 18, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/VIAL
Approval Date:	Dec 18, 2023	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2GM/VIAL
Approval Date:	Dec 18, 2023	TE:	AP	RLD:	No

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