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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 209599


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NDA 209599 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 209599
Tradename:CHOLESTYRAMINE LIGHT
Applicant:Tagi
Ingredient:cholestyramine
Patents:0
Pharmacology for NDA: 209599
Mechanism of ActionBile-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:RXDosage:POWDER;ORALStrengthEQ 4GM RESIN/PACKET
Approval Date:Nov 12, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 4GM RESIN/SCOOPFUL
Approval Date:Nov 12, 2020TE:ABRLD:No

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