Details for New Drug Application (NDA): 074557

NDA 074557 describes CHOLESTYRAMINE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Endo Operations, Epic Pharma Llc, Ivax Sub Teva Pharms, Tagi, Teva, Upsher Smith Labs, Zydus Pharms, and Teva Pharms, and is included in seventeen NDAs. It is available from twelve suppliers. Additional details are available on the CHOLESTYRAMINE profile page.

The generic ingredient in CHOLESTYRAMINE is cholestyramine. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.

Summary for 074557

Tradename:	CHOLESTYRAMINE
Applicant:	Epic Pharma Llc
Ingredient:	cholestyramine
Patents:	0

Pharmacology for NDA: 074557

Mechanism of Action

Bile-acid Binding Activity

Suppliers and Packaging for NDA: 074557

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	074557	ANDA	Eon Labs, Inc.	0185-0940	0185-0940-97	378 g in 1 CAN (0185-0940-97)
CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	074557	ANDA	Eon Labs, Inc.	0185-0940	0185-0940-98	60 POUCH in 1 CARTON (0185-0940-98) / 9 g in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 4GM RESIN/PACKET
Approval Date:	Aug 15, 1996	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 4GM RESIN/SCOOPFUL
Approval Date:	Aug 15, 1996	TE:	AB	RLD:	No

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