You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 040745


✉ Email this page to a colleague

« Back to Dashboard


NDA 040745 describes CYCLOPHOSPHAMIDE, which is a drug marketed by Alembic, Ani Pharms, Anima, Cipla, Hikma, Zydus Lifesciences, Amneal, Baxter Hlthcare, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Ingenus Pharms Llc, Sandoz, and Roxane, and is included in twenty-three NDAs. It is available from twenty-three 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-three 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.