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Generated: April 19, 2019

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Details for New Drug Application (NDA): 073263

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NDA 073263 describes PREVALITE, which is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from one supplier. Additional details are available on the PREVALITE profile page.

The generic ingredient in PREVALITE 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 073263
Applicant:Upsher Smith Labs
Formulation / Manufacturing:see details
Pharmacology for NDA: 073263
Mechanism of ActionBile-acid Binding Activity
Suppliers and Packaging for NDA: 073263
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVALITE cholestyramine POWDER;ORAL 073263 ANDA Upsher-Smith Laboratories, LLC 0245-0036 0245-0036-23 231 g in 1 CAN (0245-0036-23)
PREVALITE cholestyramine POWDER;ORAL 073263 ANDA Upsher-Smith Laboratories, LLC 0245-0036 0245-0036-42 42 PACKET in 1 CARTON (0245-0036-42) > 5.5 g in 1 PACKET (0245-0036-89)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 4GM RESIN/PACKET
Approval Date:Feb 22, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 4GM RESIN/SCOOPFUL
Approval Date:Oct 30, 1997TE:ABRLD:No

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