Details for New Drug Application (NDA): 077203

NDA 077203 describes CHOLESTYRAMINE LIGHT, which is a drug marketed by Alkem Labs Ltd, Endo Operations, Epic Pharma Llc, Tagi, Teva, Teva Pharms, and Zydus Pharms, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the CHOLESTYRAMINE LIGHT profile page.

The generic ingredient in CHOLESTYRAMINE LIGHT 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 077203

Tradename:	CHOLESTYRAMINE LIGHT
Applicant:	Endo Operations
Ingredient:	cholestyramine
Patents:	0

Pharmacology for NDA: 077203

Mechanism of Action

Bile-acid Binding Activity

Suppliers and Packaging for NDA: 077203

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHOLESTYRAMINE LIGHT	cholestyramine	POWDER;ORAL	077203	ANDA	ENDO USA, Inc.	49884-466	49884-466-50	210 g in 1 BOTTLE (49884-466-50)
CHOLESTYRAMINE LIGHT	cholestyramine	POWDER;ORAL	077203	ANDA	ENDO USA, Inc.	49884-466	49884-466-65	60 PACKET in 1 CARTON (49884-466-65) / 5 g in 1 PACKET (49884-466-63)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 4GM RESIN/PACKET
Approval Date:	Aug 26, 2005	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 26, 2005	TE:	AB	RLD:	No

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