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Product Details for NDA 012142

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CYTOXAN (CYCLOPHOSPHAMIDE)
100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYTOXAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
CYTOXAN (CYCLOPHOSPHAMIDE)
200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYTOXAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
CYTOXAN (LYOPHILIZED) (CYCLOPHOSPHAMIDE)
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYTOXAN (LYOPHILIZED)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
CYTOXAN (LYOPHILIZED) (CYCLOPHOSPHAMIDE)
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYTOXAN (LYOPHILIZED)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 008
Approval Date: Jan 4, 1984
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
CYTOXAN (LYOPHILIZED) (CYCLOPHOSPHAMIDE)
1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYTOXAN (LYOPHILIZED)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 010
Approval Date: Sep 24, 1985
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
CYTOXAN (LYOPHILIZED) (CYCLOPHOSPHAMIDE)
1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYTOXAN (LYOPHILIZED)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 004
Approval Date: Aug 30, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
CYTOXAN (LYOPHILIZED) (CYCLOPHOSPHAMIDE)
2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYTOXAN (LYOPHILIZED)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 005
Approval Date: Aug 30, 1982
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
CYTOXAN (LYOPHILIZED) (CYCLOPHOSPHAMIDE)
2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: CYTOXAN (LYOPHILIZED)
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 009
Approval Date: Dec 10, 1985
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
LYOPHILIZED CYTOXAN (CYCLOPHOSPHAMIDE)
100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: LYOPHILIZED CYTOXAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 006
Approval Date: Dec 5, 1985
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
LYOPHILIZED CYTOXAN (CYCLOPHOSPHAMIDE)
200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CYCLOPHOSPHAMIDE
Proprietary Name: LYOPHILIZED CYTOXAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N012142
Product Number: 007
Approval Date: Dec 10, 1985
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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