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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 074557


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NDA 074557 describes CHOLESTYRAMINE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Epic Pharma Llc, Ivax Sub Teva Pharms, Par Pharm, 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. Fifteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.
Summary for 074557
Tradename:CHOLESTYRAMINE
Applicant:Epic Pharma Llc
Ingredient:cholestyramine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074557
Mechanism of ActionBile-acid Binding Activity
Suppliers and Packaging for NDA: 074557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHOLESTYRAMINE cholestyramine POWDER;ORAL 074557 ANDA Eon Labs, Inc. 0185-0940 0185-0940-97 378 g in 1 CAN (0185-0940-97)
CHOLESTYRAMINE cholestyramine POWDER;ORAL 074557 ANDA Eon Labs, Inc. 0185-0940 0185-0940-98 60 POUCH in 1 CARTON (0185-0940-98) / 9 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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