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Serving leading biopharmaceutical companies globally:

Citi
McKinsey
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Queensland Health
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Deloitte
Moodys
Cerilliant
Medtronic
QuintilesIMS

Generated: January 22, 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 West-ward Pharms Int, Baxter Hlthcare, Jiangsu Hengrui Med, and Roxane, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the CYCLOPHOSPHAMIDE profile page.

The generic ingredient in CYCLOPHOSPHAMIDE is cyclophosphamide. There are eighteen drug master file entries for this compound. Five 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 10019-935-01 1 VIAL, SINGLE-DOSE in 1 CARTON (10019-935-01) > 25 mL in 1 VIAL, SINGLE-DOSE (10019-935-25)
CYCLOPHOSPHAMIDE cyclophosphamide INJECTABLE;INJECTION 040745 ANDA Baxter Healthcare Corporation 10019-936 10019-936-01 1 VIAL, SINGLE-DOSE in 1 CARTON (10019-936-01) > 50 mL in 1 VIAL, SINGLE-DOSE (10019-936-50)

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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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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Chinese Patent Office
AstraZeneca
McKinsey
Citi
Dow
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Cantor Fitzgerald

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