Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021248

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TRISENOX (ARSENIC TRIOXIDE)
2MG/ML
Marketing Status: Prescription

Active Ingredient: ARSENIC TRIOXIDE
Proprietary Name: TRISENOX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021248
Product Number: 002
Approval Date: Oct 13, 2017
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRISENOX (ARSENIC TRIOXIDE)
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ARSENIC TRIOXIDE
Proprietary Name: TRISENOX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021248
Product Number: 001
Approval Date: Sep 25, 2000
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Discontinued
Patent and Exclusivity Information