Details for New Drug Application (NDA): 211856

NDA 211856 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 211856

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

Pharmacology for NDA: 211856

Mechanism of Action

Bile-acid Binding Activity

Suppliers and Packaging for NDA: 211856

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	211856	ANDA	Bryant Ranch Prepack	63629-9196	63629-9196-1	368.76 g in 1 JAR (63629-9196-1)
CHOLESTYRAMINE	cholestyramine	POWDER;ORAL	211856	ANDA	Ascend Laboratories, LLC	67877-298	67877-298-37	368.76 g in 1 JAR (67877-298-37)

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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