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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203856

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NDA 203856 describes CYCLOPHOSPHAMIDE, which is a drug marketed by Amerigen Pharms Ltd, West-ward Pharms Int, Baxter Hlthcare, Jiangsu Hengrui Med, and Roxane, and is included in nine NDAs. It is available from four 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. Four suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
Summary for 203856
Applicant:West-ward Pharms Int
Formulation / Manufacturing:see details
Pharmacology for NDA: 203856
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 203856
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOPHOSPHAMIDE cyclophosphamide CAPSULE;ORAL 203856 NDA West-Ward Pharmaceuticals Corp. 0054-0382 N 0054-0382-25
CYCLOPHOSPHAMIDE cyclophosphamide CAPSULE;ORAL 203856 NDA West-Ward Pharmaceuticals Corp. 0054-0383 N 0054-0383-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Sep 16, 2013TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Sep 16, 2013TE:ABRLD:Yes

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