Risperidone Oral Solution

Brand(s)
Risperdal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2014-05-12)
Oldest Current Product
1996-06-10
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\RISPERIDONE
FDAOB
ORAL\SOLUTION\RISPERIDONE
SPL Active
ORAL\SOLUTION\RISPERIDONE
SPL Moiety
ORAL\SOLUTION\RISPERIDONE

product(s) by strength(s)

risperidone 1 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580596NDAJanssen Pharmaceuticals, Inc.1996-06-10RISPERIDONEORALSOLUTIONNDA020588701e1cd8-2868-4d29-85a9-a2212c88165f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540063ANDARoxane Laboratories, Inc2009-07-29RISPERIDONEORALSOLUTIONANDA076904cd742c16-c003-4c4c-8fa0-a3b4d0158383
2006039424ANDAQualitest Pharmaceuticals2010-12-03RISPERIDONEORALSOLUTIONANDA079158dd1c68bd-abba-45b3-9c3c-586d77c18853
3231550317ANDAHeritage Pharmaceuticals Inc.2013-07-15RISPERIDONEORALSOLUTIONANDA078909e3159be6-8ed3-4e6d-8368-fdfc30eb5425
4278080002ANDATris Pharma Inc2012-12-12RISPERIDONEORALSOLUTIONANDA079059a0a21bec-68f0-444e-a611-d0602859410c
5516721349ANDATaro Pharmaceuticals U.S.A., Inc.2011-02-07RISPERIDONEORALSOLUTIONANDA090347601dffbd-5987-4786-92af-853f7e60062e
6519910716ANDABreckenridge Pharmaceutical, Inc.2014-01-29RISPERIDONEORALSOLUTIONANDA0790595ceafd11-de77-4a91-9873-3ce0ae688397
7548380563ANDASilarx Pharmaceuticals, Inc2015-01-30RISPERIDONEORALSOLUTIONANDA2023861219dff4-0320-4530-b1ad-b6ecdac376cf
8551110579ANDADr. Reddy'S Laboratories Ltd2009-07-29RISPERIDONEORALSOLUTIONANDA078909b939e746-6b5f-ae82-c5f4-79cfdf6253ea
9556480692ANDAWockhardt Limited2009-10-14RISPERIDONEORALSOLUTIONANDA078744ea914046-6cc2-4c7b-b12b-76c31bb18def
10605050380ANDAApotex Corp2009-07-29RISPERIDONEORALSOLUTIONANDA07771969d0449f-95ba-dbf6-efde-6b80edee7bad
11646790692ANDAWockhardt Usa Llc.2009-10-14RISPERIDONEORALSOLUTIONANDA078744f9e04064-6b9e-4209-8149-8761f29d1cec
12651620673ANDAAmneal Pharmaceuticals2011-05-31RISPERIDONEORALSOLUTIONANDA091384bc55f60a-8121-44bb-bdfc-1d311879ba4f
13658620167ANDAAurobindo Pharma Limited2009-09-15RISPERIDONEORALSOLUTIONANDA078452c4582bdf-5eda-438c-98b4-0517500501e8

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178560380ANDAAtlantic Biologicals Corps2011-05-31RISPERIDONEORALSOLUTION651620673ANDA091384dae5ec58-85c1-4503-a6b8-56696dd1e6fc

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076440RISPERIDONEANI PHARMACEUTICALS INC2009-01-30ANDA076440_001
2ANDA076797RISPERIDONEPRECISION DOSE INC2010-06-28ANDA076797_001
3ANDA076904RISPERIDONEROXANE LABORATORIES INC2009-07-29ANDA076904_001
4ANDA077719RISPERIDONEAPOTEX INC RICHMOND HILL2009-07-29ANDA077719_001
5ANDA078452RISPERIDONEAUROBINDO PHARMA LTD2009-09-04ANDA078452_001
6ANDA078744RISPERIDONEWOCKHARDT LTD2009-10-08ANDA078744_001
7ANDA078909RISPERIDONEBIO PHARM INC2009-07-29ANDA078909_001
8ANDA079059RISPERIDONETRIS PHARMA INC2012-12-12ANDA079059_001
9ANDA079158RISPERIDONEVINTAGE PHARMACEUTICALS LLC2010-12-03ANDA079158_001
10ANDA090347RISPERIDONETARO PHARMACEUTICALS USA INC2011-02-07ANDA090347_001
11ANDA091384RISPERIDONEAMNEAL PHARMACEUTICALS2011-05-25ANDA091384_001
12ANDA202386RISPERIDONESILARX PHARMACEUTICALS INC2015-01-12ANDA202386_001
13NDA020588RISPERDALJANSSEN PHARMACEUTICALS INC1996-06-10pRE39181, SUBSTANCE
p5453425, SUBSTANCE
NDA020588_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076440_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2009-01-30RISPERIDONE
2ANDA076797_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2010-06-28RISPERIDONE
3ANDA076904_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2009-07-29RISPERIDONE
4ANDA077719_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2009-07-29RISPERIDONE
5ANDA078452_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2009-09-04RISPERIDONE
6ANDA078744_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2009-10-08RISPERIDONE
7ANDA078909_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2009-07-29RISPERIDONE
8ANDA079059_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2012-12-12RISPERIDONE
9ANDA079158_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2010-12-03RISPERIDONE
10ANDA090347_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2011-02-07RISPERIDONE
11ANDA091384_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2011-05-25RISPERIDONE
12ANDA202386_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONFalseAA2015-01-12RISPERIDONE
13NDA020588_001RXRISPERIDONE (1MG/ML)ORALSOLUTIONTrueAA1996-06-10RISPERDAL

patent(s)

#idexpiration dateapplication(s)
1p5453425 (view patent)2014-07-11NDA020588
2pRE39181 (view patent)2014-07-11NDA020588

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11219dff4-0320-4530-b1ad-b6ecdac376cf (view SPL)These highlights do not include all the information needed to use Risperidone safely and effectively. See full prescribing information for Risperidone. Risperidone oral solution, for oral use.Initial U.S. Approval: 1993prescriptionHuman PrescriptionSilarx Pharmaceuticals, IncANALYSIS, LABEL, MANUFACTURE, PACK2015-01-233548380563
25ceafd11-de77-4a91-9873-3ce0ae688397 (view SPL)These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for Risperidone Oral Solution, USP. RISPERIDONE ORAL SOLUTION, USP Initial U.S. Approval: 1993prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2013-09-302519910716
3601dffbd-5987-4786-92af-853f7e60062e (view SPL)These highlights do not include all the information needed to use Risperidone safely and effectively. See full prescribing Information for Risperidone Oral Solution USP.Initial U.S. Approval: 1993prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2012-01-113516721349
469d0449f-95ba-dbf6-efde-6b80edee7bad (view SPL)These highlights do not include all the information needed to use RISPERIDONE oral solution, USP safely and effectively. See full prescribing information for RISPERIDONE oral solution, USP. RISPERIDONE Oral Solution, USP 1 mg/mL Initial U.S. Approval: 1993prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-07-174605050380
5701e1cd8-2868-4d29-85a9-a2212c88165f (view SPL)These highlights do not include all the information needed to use Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets. Risperidone Tablets, Risperidone Oral Solution, Risperidone Orally Disintegrating Tablets Initial U.S. Approval: 1993prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-05-1210504580596, 504580590, 504580591, 504580592, 504580593, 504580594, 504580595, 504580601, 504580602, 504580603, 504580604, 504580605Risperidone Oral Tablet
Risperidone Disintegrating Oral Tablet
67e117c7e-02fc-4343-92a1-230061dfc5e0 (view SPL)These highlights do not include all the information needed to use RISPERDAL safely and effectively. See full prescribing information for RISPERDAL. RISPERDAL (risperidone) tablets, for oral use RISPERDAL (risperidone) oral solution RISPERDAL M-TAB (risperidone) orally disintegrating tablets Initial U.S. Approval: 1993prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-05-0615504580300, 504580301, 504580302, 504580305, 504580315, 504580320, 504580325, 504580330, 504580335, 504580350, 504580355, 504580395Risperidone Oral Tablet
Risperidone Disintegrating Oral Tablet
7a0a21bec-68f0-444e-a611-d0602859410c (view SPL)These highlights do not include all the information needed to use Risperidone safely and effectively. See full prescribing information for Risperidone. Risperidone (Risperidone) SOLUTION for ORAL use.Initial U.S. Approval: 1994prescriptionHuman PrescriptionTris Pharma IncANALYSIS, API MANUFACTURE, MANUFACTURE2012-12-121278080002
8b939e746-6b5f-ae82-c5f4-79cfdf6253ea (view SPL)These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Oral Solution USP Initial U.S. Approval: 1993prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2011-11-059551110579
9bc55f60a-8121-44bb-bdfc-1d311879ba4f (view SPL)These highlights do not include all the information needed to use Risperidone safely and effectively. See full prescribing information for Risperidone. Risperidone (Risperidone) SOLUTION for ORAL use.Initial U.S. Approval: 1993prescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-01-0110651620673
10c4582bdf-5eda-438c-98b4-0517500501e8 (view SPL)These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone oral solution, USP. RISPERIDONE Oral Solution, USPInitial U.S. Approval: 1993prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-11-0713658620167
11cd742c16-c003-4c4c-8fa0-a3b4d0158383 (view SPL)These highlights do not include all the information needed to use Risperidone Oral Solution, USP safely and effectively. See full prescribing information for Risperidone Oral Solution, USP.Risperidone Oral Solution, USP, for oral useInitial U.S. Approval: 1993prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-10-297000540063
12dae5ec58-85c1-4503-a6b8-56696dd1e6fc (view SPL)These highlights do not include all the information needed to use Risperidone safely and effectively. see full prescribing information for Risperidone. Risperidone (Risperidone) SOLUTION for ORAL use. Initial U.S. Approval: 1993prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2011-05-312178560380
13dd1c68bd-abba-45b3-9c3c-586d77c18853 (view SPL)These highlights do not include all the information needed to useRisperidone oral solution USPsafely and effectively. See full prescribing information for Risperidone oral solution USP. Risperidone Oral Solution USP Initial U.S. Approval: 1993prescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2014-06-1817006039424
14e3159be6-8ed3-4e6d-8368-fdfc30eb5425 (view SPL)These highlights do not include all the information needed to use Risperidone safely and effectively. See full prescribing information for Risperidone. Risperidone (Risperidone) SOLUTION for ORAL use.Initial U.S. Approval: 1993prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2014-07-032231550317
15ea914046-6cc2-4c7b-b12b-76c31bb18def (view SPL)These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993prescriptionHuman PrescriptionWockhardt Limited2010-11-101556480692
16f9e04064-6b9e-4209-8149-8761f29d1cec (view SPL)These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993prescriptionHuman PrescriptionWockhardt Usa Llc.2009-10-141646790692

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