Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212928

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PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
225MG
Marketing Status: Prescription

Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: PROPAFENONE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 225MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212928
Product Number: 001
Approval Date: Jun 18, 2020
Applicant Holder Full Name: TWI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
325MG
Marketing Status: Prescription

Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: PROPAFENONE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 325MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212928
Product Number: 002
Approval Date: Jun 18, 2020
Applicant Holder Full Name: TWI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
425MG
Marketing Status: Prescription

Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: PROPAFENONE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 425MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212928
Product Number: 003
Approval Date: Jun 18, 2020
Applicant Holder Full Name: TWI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information