U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 075371

Expand all

DACARBAZINE (DACARBAZINE)
100MG/VIAL
Marketing Status: Prescription
Active Ingredient: DACARBAZINE
Proprietary Name: DACARBAZINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A075371
Product Number: 001
Approval Date: Aug 27, 1999
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
DACARBAZINE (DACARBAZINE)
200MG/VIAL
Marketing Status: Prescription
Active Ingredient: DACARBAZINE
Proprietary Name: DACARBAZINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A075371
Product Number: 002
Approval Date: Aug 27, 1999
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top