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Generated: December 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077204

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NDA 077204 describes CHOLESTYRAMINE, which is a drug marketed by Ani Pharms Inc, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Teva, Zydus Pharms Usa Inc, and Teva Pharms, and is included in eleven NDAs. It is available from six 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. Eight suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.
Summary for 077204
Applicant:Par Pharm
Formulation / Manufacturing:see details
Pharmacology for NDA: 077204
Mechanism of ActionBile-acid Binding Activity
Suppliers and Packaging for NDA: 077204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHOLESTYRAMINE cholestyramine POWDER;ORAL 077204 ANDA Par Pharmaceutical, Inc. 49884-465 49884-465-65 60 PACKET in 1 CARTON (49884-465-65) > 9 g in 1 PACKET (49884-465-64)
CHOLESTYRAMINE cholestyramine POWDER;ORAL 077204 ANDA Par Pharmaceutical, Inc. 49884-465 49884-465-66 378 g in 1 CAN (49884-465-66)

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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