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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204555

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NDA 204555 describes CYCLOPHOSPHAMIDE, which is a drug marketed by Amerigen Pharms Ltd, Sti Pharma Llc, West-ward Pharms Int, Baxter Hlthcare, Jiangsu Hengrui Med, and Roxane, and is included in ten NDAs. It is available from seven suppliers. 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. Seven suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
Summary for 204555
Tradename:CYCLOPHOSPHAMIDE
Applicant:Jiangsu Hengrui Med
Ingredient:cyclophosphamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204555
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 204555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 204555 ANDA Sandoz Inc. 0781-3233 N 0781-3233-94
CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 204555 ANDA Sandoz Inc. 0781-3244 N 0781-3244-94

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Oct 31, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Oct 31, 2014TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/VIAL
Approval Date:Oct 31, 2014TE:APRLD:No

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