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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 214877


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NDA 214877 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 214877
Tradename:CHOLESTYRAMINE
Applicant:Upsher Smith Labs
Ingredient:cholestyramine
Patents:0
Pharmacology for NDA: 214877
Mechanism of ActionBile-acid Binding Activity
Suppliers and Packaging for NDA: 214877
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHOLESTYRAMINE cholestyramine POWDER;ORAL 214877 ANDA Upsher-Smith Laboratories,LLC 0832-0536 0832-0536-42 42 POUCH in 1 CARTON (0832-0536-42) / 9 g in 1 POUCH (0832-0536-89)
CHOLESTYRAMINE cholestyramine POWDER;ORAL 214877 ANDA Upsher-Smith Laboratories,LLC 0832-0536 0832-0536-60 60 CAN in 1 CARTON (0832-0536-60) / 378 g in 1 CAN (0832-0536-37)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;ORALStrengthEQ 4GM RESIN/PACKET
Approval Date:Jan 21, 2022TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;ORALStrengthEQ 4GM RESIN/SCOOPFUL
Approval Date:Jan 21, 2022TE:RLD:No

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