Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215059

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ARSENIC TRIOXIDE (ARSENIC TRIOXIDE)
1MG/ML
Marketing Status: Prescription

Active Ingredient: ARSENIC TRIOXIDE
Proprietary Name: ARSENIC TRIOXIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215059
Product Number: 002
Approval Date: Apr 22, 2022
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: ARSENIC TRIOXIDE
Proprietary Name: ARSENIC TRIOXIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215059
Product Number: 001
Approval Date: Oct 7, 2021
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information