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Last Updated: November 17, 2024

Details for New Drug Application (NDA): 210852

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NDA 210852 describes CYCLOPHOSPHAMIDE, which is a drug marketed by Alembic, Ani Pharms, Cipla, Hikma, Kanchan Hlthcare, Zydus Lifesciences, Amneal, Baxter Hlthcare, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Avyxa Holdings, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Sandoz, and Roxane, and is included in twenty-three NDAs. It is available from twenty-four suppliers. There are four 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 210852

Tradename:	CYCLOPHOSPHAMIDE
Applicant:	Avyxa Holdings
Ingredient:	cyclophosphamide
Patents:	2

Medical Subject Heading (MeSH) Categories for 210852

Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunosuppressive Agents
Mutagens
Myeloablative Agonists

Suppliers and Packaging for NDA: 210852

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	210852	NDA	Avyxa Pharma, LLC	83831-116	83831-116-01	1 VIAL, SINGLE-DOSE in 1 CARTON (83831-116-01) / 1 mL in 1 VIAL, SINGLE-DOSE
CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	210852	NDA	Avyxa Pharma, LLC	83831-117	83831-117-02	1 VIAL, SINGLE-DOSE in 1 CARTON (83831-117-02) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	500MG/ML (500MG/ML)
Approval Date:	Jun 7, 2023	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 13, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 1, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1GM/2ML (500MG/ML)
Approval Date:	Jun 7, 2023	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 13, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

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