Details for New Drug Application (NDA): 211799

NDA 211799 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 211799

Tradename:	CHOLESTYRAMINE LIGHT
Applicant:	Alkem Labs Ltd
Ingredient:	cholestyramine
Patents:	0

Pharmacology for NDA: 211799

Mechanism of Action

Bile-acid Binding Activity

Suppliers and Packaging for NDA: 211799

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHOLESTYRAMINE LIGHT	cholestyramine	POWDER;ORAL	211799	ANDA	Bryant Ranch Prepack	63629-9466	63629-9466-1	60 POUCH in 1 CARTON (63629-9466-1) / 5.718 g in 1 POUCH
CHOLESTYRAMINE LIGHT	cholestyramine	POWDER;ORAL	211799	ANDA	Ascend Laboratories, LLC	67877-422	67877-422-24	240.156 g in 1 JAR (67877-422-24)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 4GM RESIN/PACKET
Approval Date:	Oct 19, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 4GM RESIN/SCOOPFUL
Approval Date:	Oct 19, 2021	TE:	AB	RLD:	No

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