Last Updated: September 26, 2026

Details for New Drug Application (NDA): 088072

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NDA 088072 describes QUINIDINE SULFATE, which is a drug marketed by Lilly, Cosette Pharms Nc, Barr, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Cycle, Dava Pharms Inc, Elkins Sinn, Epic Pharma Llc, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, King Pharms, Kv Pharm, Lederle, Perrigo, Pharmavite, Purepac Pharm, Sandoz, Scherer Labs, Sun Pharm Industries, Superpharm, Usl Pharma, Valeant Pharm Intl, Vangard, Vintage Pharms, Warner Chilcott, Watson Labs, and Whiteworth Town Plsn, and is included in forty NDAs. It is available from one supplier. Additional details are available on the QUINIDINE SULFATE profile page.

The generic ingredient in QUINIDINE SULFATE is quinidine sulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the quinidine sulfate profile page.

Summary for 088072

Tradename:	QUINIDINE SULFATE
Applicant:	Epic Pharma Llc
Ingredient:	quinidine sulfate
Patents:	0

Pharmacology for NDA: 088072

Mechanism of Action	Cytochrome P450 2D6 Inhibitors

Suppliers and Packaging for NDA: 088072

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-512	42806-512-01	100 TABLET in 1 BOTTLE (42806-512-01)
QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-512	42806-512-30	30 TABLET in 1 BOTTLE (42806-512-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Sep 26, 1983	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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