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Farmers Insurance
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Cantor Fitzgerald
Harvard Business School
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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040745

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NDA 040745 describes CYCLOPHOSPHAMIDE, which is a drug marketed by Amerigen Pharms Ltd, Sti Pharma Llc, West-ward Pharms Int, Amneal Pharms Co, Baxter Hlthcare, Jiangsu Hengrui Med, and Roxane, and is included in eleven NDAs. It is available from eight 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. Eight suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
Summary for 040745
Tradename:CYCLOPHOSPHAMIDE
Applicant:Baxter Hlthcare
Ingredient:cyclophosphamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040745
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 040745
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 040745 ANDA Baxter Healthcare Corporation 10019-935 N 10019-935-01
CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 040745 ANDA Baxter Healthcare Corporation 10019-936 N 10019-936-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:May 21, 2008TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:May 21, 2008TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/VIAL
Approval Date:May 21, 2008TE:APRLD:No

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