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Generated: May 26, 2019

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Details for New Drug Application (NDA): 077203

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NDA 077203 describes CHOLESTYRAMINE LIGHT, which is a drug marketed by Par Pharm, Sandoz, Teva, Teva Pharms, and Zydus Pharms Usa Inc, and is included in five NDAs. It is available from five 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 077203
Applicant:Par Pharm
Formulation / Manufacturing:see details
Pharmacology for NDA: 077203
Mechanism of ActionBile-acid Binding Activity
Suppliers and Packaging for NDA: 077203
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 077203 ANDA Par Pharmaceutical, Inc. 49884-466 49884-466-65 60 PACKET in 1 CARTON (49884-466-65) > 5 g in 1 PACKET (49884-466-63)
CHOLESTYRAMINE LIGHT cholestyramine POWDER;ORAL 077203 ANDA Par Pharmaceutical, Inc. 49884-466 49884-466-67 210 g in 1 CAN (49884-466-67)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 4GM RESIN/PACKET
Approval Date:Aug 26, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 4GM RESIN/SCOOPFUL
Approval Date:Aug 26, 2005TE:ABRLD:No

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