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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017575

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DTIC-DOME (DACARBAZINE)
100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DACARBAZINE
Proprietary Name: DTIC-DOME
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Strength: 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017575
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DTIC-DOME (DACARBAZINE)
200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DACARBAZINE
Proprietary Name: DTIC-DOME
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Strength: 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017575
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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