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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
McKinsey
Dow
Merck
Queensland Health
Cipla
Express Scripts
US Army
Boehringer Ingelheim

Generated: December 12, 2017

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 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 012142

Tradename:3
Applicant:1
Ingredient:1
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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 012142

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter HlthcareLYOPHILIZED CYTOXANcyclophosphamideINJECTABLE;INJECTION012142-006Dec 5, 1985► Subscribe► Subscribe
Baxter HlthcareCYTOXAN (LYOPHILIZED)cyclophosphamideINJECTABLE;INJECTION012142-009Dec 10, 1985► Subscribe► Subscribe
Baxter HlthcareCYTOXAN (LYOPHILIZED)cyclophosphamideINJECTABLE;INJECTION012142-010Sep 24, 1985► Subscribe► Subscribe
Baxter HlthcareCYTOXAN (LYOPHILIZED)cyclophosphamideINJECTABLE;INJECTION012142-008Jan 4, 1984► Subscribe► Subscribe
Baxter HlthcareLYOPHILIZED CYTOXANcyclophosphamideINJECTABLE;INJECTION012142-007Dec 10, 1985► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
Argus Health
Mallinckrodt
Citi
Harvard Business School
Merck
US Army
Express Scripts
Covington

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