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Generated: October 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012142

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NDA 012142 describes LYOPHILIZED CYTOXAN, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the LYOPHILIZED CYTOXAN profile page.

The generic ingredient in LYOPHILIZED CYTOXAN is cyclophosphamide. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.
Summary for 012142
Tradename:LYOPHILIZED CYTOXAN
Applicant:Baxter Hlthcare
Ingredient:cyclophosphamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 012142
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 012142
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYTOXAN cyclophosphamide INJECTABLE;INJECTION 012142 NDA Baxter Healthcare Corporation 10019-988 10019-988-01 1 VIAL, SINGLE-DOSE in 1 CARTON (10019-988-01) > 25 mL in 1 VIAL, SINGLE-DOSE
CYTOXAN (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142 NDA Baxter Healthcare Corporation 10019-988 10019-988-01 1 VIAL, SINGLE-DOSE in 1 CARTON (10019-988-01) > 25 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 012142

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare LYOPHILIZED CYTOXAN cyclophosphamide INJECTABLE;INJECTION 012142-007 Dec 10, 1985 ➤ Sign Up ➤ Sign Up
Baxter Hlthcare CYTOXAN (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142-010 Sep 24, 1985 ➤ Sign Up ➤ Sign Up
Baxter Hlthcare CYTOXAN (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142-008 Jan 4, 1984 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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