Product Details for NDA 019151
RYTHMOL (PROPAFENONE HYDROCHLORIDE)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: RYTHMOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019151
Product Number: 001
Approval Date: Nov 27, 1989
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
RYTHMOL (PROPAFENONE HYDROCHLORIDE)
Proprietary Name: RYTHMOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019151
Product Number: 001
Approval Date: Nov 27, 1989
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: RYTHMOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019151
Product Number: 003
Approval Date: Nov 20, 1992
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
RYTHMOL (PROPAFENONE HYDROCHLORIDE)
Proprietary Name: RYTHMOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 225MG **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: N019151
Product Number: 003
Approval Date: Nov 20, 1992
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: RYTHMOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG **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: N019151
Product Number: 002
Approval Date: Nov 27, 1989
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: RYTHMOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG **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: N019151
Product Number: 002
Approval Date: Nov 27, 1989
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information