Details for New Drug Application (NDA): 209599

NDA 209599 describes CHOLESTYRAMINE LIGHT, which is a drug marketed by Alkem Labs Ltd, Endo Operations, Epic Pharma Llc, Macleods Pharms Ltd, Tagi, Teva, Teva Pharms, and Zydus Pharms, and is included in eight 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 209599

Tradename:	CHOLESTYRAMINE LIGHT
Applicant:	Tagi
Ingredient:	cholestyramine
Patents:	0

Pharmacology for NDA: 209599

Mechanism of Action

Bile-acid Binding Activity

Suppliers and Packaging for NDA: 209599

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHOLESTYRAMINE LIGHT	cholestyramine	POWDER;ORAL	209599	ANDA	TAGI Pharma, Inc.	51224-009	51224-009-10	201.6 g in 1 CAN (51224-009-10)
CHOLESTYRAMINE LIGHT	cholestyramine	POWDER;ORAL	209599	ANDA	TAGI Pharma, Inc.	51224-009	51224-009-20	60 POUCH in 1 CARTON (51224-009-20) / 4.8 g in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 4GM RESIN/PACKET
Approval Date:	Nov 12, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	EQ 4GM RESIN/SCOOPFUL
Approval Date:	Nov 12, 2020	TE:	AB	RLD:	No

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