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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 212501

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NDA 212501 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 212501

Tradename:	CYCLOPHOSPHAMIDE
Applicant:	Dr Reddys
Ingredient:	cyclophosphamide
Patents:	2

Medical Subject Heading (MeSH) Categories for 212501

Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunosuppressive Agents
Mutagens
Myeloablative Agonists

Suppliers and Packaging for NDA: 212501

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	212501	NDA	BluePoint Laboratories	68001-564	68001-564-22	1 VIAL in 1 CARTON (68001-564-22) / 5 mL in 1 VIAL
CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	212501	NDA	BluePoint Laboratories	68001-565	68001-565-28	1 VIAL in 1 CARTON (68001-565-28) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	500MG/2.5ML (200MG/ML)
Approval Date:	Jul 30, 2020	TE:	AP	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 15, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 15, 2036	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1GM/5ML (200MG/ML)
Approval Date:	Jul 30, 2020	TE:	AP	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 15, 2036	Product Flag?	Y	Substance Flag?		Delist Request?

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