Details for New Drug Application (NDA): 089338

NDA 089338 describes QUINIDINE GLUCONATE, which is a drug marketed by Lilly, Ani Pharms, Ascot, Cycle, Eywa, Halsey, Rising, Sun Pharm Industries, Superpharm, and Watson Labs, and is included in ten NDAs. It is available from four suppliers. Additional details are available on the QUINIDINE GLUCONATE profile page.

The generic ingredient in QUINIDINE GLUCONATE is quinidine gluconate. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the quinidine gluconate profile page.

Summary for 089338

Tradename:	QUINIDINE GLUCONATE
Applicant:	Sun Pharm Industries
Ingredient:	quinidine gluconate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 089338

Mechanism of Action

Cytochrome P450 2D6 Inhibitors

Suppliers and Packaging for NDA: 089338

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
QUINIDINE GLUCONATE	quinidine gluconate	TABLET, EXTENDED RELEASE;ORAL	089338	ANDA	Golden State Medical Supply	51407-288	51407-288-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-288-01)
QUINIDINE GLUCONATE	quinidine gluconate	TABLET, EXTENDED RELEASE;ORAL	089338	ANDA	Sun Pharmaceutical Industries, Inc.	53489-141	53489-141-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	324MG
Approval Date:	Feb 11, 1987	TE:	AB	RLD:	No

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