Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215323

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DOFETILIDE (DOFETILIDE)
0.125MG
Marketing Status: Discontinued

Active Ingredient: DOFETILIDE
Proprietary Name: DOFETILIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A215323
Product Number: 001
Approval Date: Apr 14, 2022
Applicant Holder Full Name: RK PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DOFETILIDE (DOFETILIDE)
0.25MG
Marketing Status: Discontinued

Active Ingredient: DOFETILIDE
Proprietary Name: DOFETILIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A215323
Product Number: 002
Approval Date: Apr 14, 2022
Applicant Holder Full Name: RK PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DOFETILIDE (DOFETILIDE)
0.5MG
Marketing Status: Discontinued

Active Ingredient: DOFETILIDE
Proprietary Name: DOFETILIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A215323
Product Number: 003
Approval Date: Apr 14, 2022
Applicant Holder Full Name: RK PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information