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Last Updated: January 23, 2021

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Details for New Drug Application (NDA): 074558

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NDA 074558 describes CHOLESTYRAMINE LIGHT, which is a drug marketed by Par Pharm, Sandoz, Teva, Teva Pharms, and Zydus Pharms, and is included in five NDAs. It is available from four 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. Eight suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.
Summary for 074558
Formulation / Manufacturing:see details
Pharmacology for NDA: 074558
Mechanism of ActionBile-acid Binding Activity
Suppliers and Packaging for NDA: 074558
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 074558 ANDA Eon Labs, Inc. 0185-0939 0185-0939-97 239.4 g in 1 CAN (0185-0939-97)
CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 074558 ANDA Eon Labs, Inc. 0185-0939 0185-0939-98 60 POUCH in 1 CARTON (0185-0939-98) > 5.7 g in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 4GM RESIN/PACKET
Approval Date:Aug 15, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 4GM RESIN/SCOOPFUL
Approval Date:Aug 15, 1996TE:ABRLD:No

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