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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 040045

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NDA 040045 describes QUINIDINE SULFATE, which is a drug marketed by Lilly, Cosette, 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 are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the quinidine sulfate profile page.

Summary for 040045

Tradename:	QUINIDINE SULFATE
Applicant:	Cosette
Ingredient:	quinidine sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Jun 30, 1994	TE:		RLD:	No

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