Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076550

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PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
150MG
Marketing Status: Prescription

Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: PROPAFENONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076550
Product Number: 001
Approval Date: Apr 23, 2004
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: PROPAFENONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 225MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076550
Product Number: 002
Approval Date: Apr 23, 2004
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
300MG
Marketing Status: Prescription

Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: PROPAFENONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076550
Product Number: 003
Approval Date: Apr 23, 2004
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information