Details for New Drug Application (NDA): 077204

NDA 077204 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, Macleods Pharms Ltd, and Teva Pharms, and is included in eighteen 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 077204

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

Pharmacology for NDA: 077204

Mechanism of Action

Bile-acid Binding Activity

Suppliers and Packaging for NDA: 077204

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	077204	ANDA	Endo USA, Inc.	49884-465	49884-465-65	60 PACKET in 1 CARTON (49884-465-65) / 9 g in 1 PACKET (49884-465-64)
CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	077204	ANDA	Endo USA, Inc.	49884-465	49884-465-66	378 g in 1 CAN (49884-465-66)

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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