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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 218282

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NDA 218282 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 218282

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

Medical Subject Heading (MeSH) Categories for 218282

Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunosuppressive Agents
Mutagens
Myeloablative Agonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Dec 3, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Dec 3, 2024	TE:	AB	RLD:	No

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