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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 seventeen 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 NDA: 012142

Tradename:
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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength200MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 012142

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare
CYTOXAN (LYOPHILIZED)
cyclophosphamide
INJECTABLE;INJECTION012142-010Sep 24, 19854,537,883► subscribe
Baxter Hlthcare
LYOPHILIZED CYTOXAN
cyclophosphamide
INJECTABLE;INJECTION012142-007Dec 10, 19854,537,883► subscribe
Baxter Hlthcare
LYOPHILIZED CYTOXAN
cyclophosphamide
INJECTABLE;INJECTION012142-006Dec 5, 19854,537,883► subscribe
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