Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021416

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RYTHMOL SR (PROPAFENONE HYDROCHLORIDE)
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)
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)
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