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Details for New Drug Application (NDA): 019151

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NDA 019151 describes RYTHMOL, which is a drug marketed by Glaxosmithkline Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the RYTHMOL profile page.

The generic ingredient in RYTHMOL is propafenone hydrochloride. There are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

Summary for NDA: 019151

Glaxosmithkline Llc
propafenone hydrochloride
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 019151

Suppliers and Packaging for NDA: 019151

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
propafenone hydrochloride
TABLET;ORAL 019151 NDA GlaxoSmithKline LLC 0173-0792 0173-0792-20 100 TABLET, FILM COATED in 1 BOTTLE (0173-0792-20)
propafenone hydrochloride
TABLET;ORAL 019151 NDA GlaxoSmithKline LLC 0173-0794 0173-0794-20 100 TABLET, FILM COATED in 1 BOTTLE (0173-0794-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 27, 1989TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Nov 27, 1989TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength225MG
Approval Date:Nov 20, 1992TE:ABRLD:No

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