Colestipol Oral Tablet

Brand(s)
Colestid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-07-02)
Oldest Current Product
1994-07-19
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\COLESTIPOL
FDAOB
ORAL\TABLET\COLESTIPOL HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\COLESTIPOL HYDROCHLORIDE
ORAL\TABLET\COLESTIPOL HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\COLESTIPOL
ORAL\TABLET\COLESTIPOL

product(s) by strength(s)

colestipol hydrochloride 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090450ColestidNDAPharmacia And Upjohn Company1994-07-19COLESTIPOL HYDROCHLORIDEORALTABLETNDA0202223e270911-f27b-44d4-b0a2-33506418cc1d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001155211ANDAGlobal Pharmaceuticals2006-10-24COLESTIPOL HYDROCHLORIDEORALTABLET, FILM COATEDANDA077510fa6c3e11-84e9-433d-aa74-7cd34336bbed
2597620450NDA AUTHORIZED GENERICGreenstone Llc1994-07-19COLESTIPOL HYDROCHLORIDEORALTABLETNDA020222dae7d51e-c117-4c8a-b018-45b01ae46100

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680610NDA AUTHORIZED GENERICPhysicians Total Care, Inc.2007-02-28COLESTIPOL HYDROCHLORIDEORALTABLET597620450NDA020222ece20a8d-3d58-4f4a-8a96-348cfdf8392e
2681514361NDA AUTHORIZED GENERICCarilion Materials Management1994-07-19COLESTIPOL HYDROCHLORIDEORALTABLET597620450NDA020222fbd848be-fb6a-495c-80bc-a9e9ed18e15f

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077510COLESTIPOL HYDROCHLORIDEIMPAX LABORATORIES INC2006-10-24ANDA077510_001
2NDA020222COLESTIDPHARMACIA AND UPJOHN CO1994-07-19NDA020222_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077510_001RXCOLESTIPOL HYDROCHLORIDE (1GM)ORALTABLETFalseAB2006-10-24COLESTIPOL HYDROCHLORIDE
2NDA020222_001RXCOLESTIPOL HYDROCHLORIDE (1GM)ORALTABLETTrueAB1994-07-19COLESTID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13e270911-f27b-44d4-b0a2-33506418cc1d (view SPL)Colestid micronized colestipolhydrochloride tabletsprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-07-025000090450
2dae7d51e-c117-4c8a-b018-45b01ae46100 (view SPL)Micronized Colestipol Hydrochloride TabletsprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-08-084597620450
3ece20a8d-3d58-4f4a-8a96-348cfdf8392e (view SPL)Micronized Colestipol Hydrochloride TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-12-211548680610
4fa6c3e11-84e9-433d-aa74-7cd34336bbed (view SPL)COLESTIPOL HYDROCHLORIDE TABLETS, 1 GRAMprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2013-11-183001155211
5fbd848be-fb6a-495c-80bc-a9e9ed18e15f (view SPL)Micronized Colestipol Hydrochloride TabletsprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-08-082681514361

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII