Product Details for NDA 021416
RYTHMOL SR (PROPAFENONE HYDROCHLORIDE)
225MG
Marketing Status: Discontinued
325MG
Marketing Status: Discontinued
425MG
Marketing Status: Discontinued
225MG
Marketing Status: Discontinued
Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: RYTHMOL SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 225MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021416
Product Number: 001
Approval Date: Sep 4, 2003
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
RYTHMOL SR (PROPAFENONE HYDROCHLORIDE)
Proprietary Name: RYTHMOL SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 225MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021416
Product Number: 001
Approval Date: Sep 4, 2003
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
325MG
Marketing Status: Discontinued
Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: RYTHMOL SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 325MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021416
Product Number: 002
Approval Date: Sep 4, 2003
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
RYTHMOL SR (PROPAFENONE HYDROCHLORIDE)
Proprietary Name: RYTHMOL SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 325MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021416
Product Number: 002
Approval Date: Sep 4, 2003
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
425MG
Marketing Status: Discontinued
Active Ingredient: PROPAFENONE HYDROCHLORIDE
Proprietary Name: RYTHMOL SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 425MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021416
Product Number: 003
Approval Date: Sep 4, 2003
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: RYTHMOL SR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 425MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021416
Product Number: 003
Approval Date: Sep 4, 2003
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information