Ondansetron Oral Solution

Brand(s)
Zofran
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-10-01)
Oldest Current Product
1997-02-05
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\ONDANSETRON
FDAOB
ORAL\SOLUTION\ONDANSETRON HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\ONDANSETRON HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\ONDANSETRON

product(s) by strength(s)

ondansetron 0.8 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730489ZofranNDAGlaxosmithkline Llc1997-02-05ONDANSETRON HYDROCHLORIDEORALSOLUTIONNDA020605c7d61d98-fe86-4340-9b86-47eb92acaa0e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540064ANDARoxane Laboratories, Inc2006-12-26ONDANSETRON HYDROCHLORIDEORALSOLUTIONANDA0769601a0c4dc6-643e-4ee7-92a9-edb98049a5ba
2167140671ANDANorthstar Rx Llc2007-11-28ONDANSETRON HYDROCHLORIDEORALSOLUTIONANDA078776ac3dfb81-a4c7-4147-9374-c234153b7c51
3516724091ANDATaro Pharmaceuticals U.S.A., Inc.2007-11-30ONDANSETRON HYDROCHLORIDEORALSOLUTIONANDA077009a95ca4f4-c4de-4822-9a08-209d10bf5136
4548380555ANDASilarx Pharmaceuticals, Inc2011-01-27ONDANSETRON HYDROCHLORIDEORALSOLUTIONANDA091342e6c549a7-774f-4274-9bc5-1149fed5c526
5605050381ANDAApotex Corp2008-03-13ONDANSETRON HYDROCHLORIDEORALSOLUTIONANDA078127b4f49bd9-67e4-37be-f936-28876681f14b
6651620691ANDAAmneal Pharmaceuticals2010-12-17ONDANSETRON HYDROCHLORIDEORALSOLUTIONANDA09148338435346-d505-4bdd-bbc6-a7bcba411033
7658620208ANDAAurobindo Pharma Limited2007-11-28ONDANSETRON HYDROCHLORIDEORALSOLUTIONANDA078776cf10d256-dd89-4a91-a3ed-81db505a79c2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178560691ANDAAtlantic Biologicals Corps2010-12-17ONDANSETRON HYDROCHLORIDEORALSOLUTION651620691ANDA091483e5ab38a2-5921-4320-a313-e0080c078046
2178564091ANDAAtlantic Biologicals Corps2010-12-17ONDANSETRON HYDROCHLORIDEORALSOLUTION651620691ANDA0914837a3c9566-1847-4867-b528-0e91fb8bab94
3680940325ANDAPrecision Dose Inc.2010-05-11ONDANSETRON HYDROCHLORIDEORALSOLUTION516724091ANDA077009ddbeb79e-90d4-4c83-9b69-e7915867edbe
4680940763ANDAPrecision Dose Inc.2015-02-27ONDANSETRON HYDROCHLORIDEORALSOLUTION000540064ANDA07696004800a86-2391-44e6-8763-d65e8a916c26

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076960ONDANSETRON HYDROCHLORIDEROXANE LABORATORIES INC2006-12-26ANDA076960_001
2ANDA077009ONDANSETRON HYDROCHLORIDETARO PHARMACEUTICAL INDUSTRIES LTD2007-11-30ANDA077009_001
3ANDA078127ONDANSETRON HYDROCHLORIDEAPOTEX INC2007-06-25ANDA078127_001
4ANDA078776ONDANSETRON HYDROCHLORIDEAUROBINDO PHARMA LTD2007-11-28ANDA078776_001
5ANDA091342ONDANSETRON HYDROCHLORIDESILARX PHARMACEUTICALS INC2011-01-27ANDA091342_001
6ANDA091483ONDANSETRON HYDROCHLORIDEAMNEAL PHARMACEUTICALS2011-01-31ANDA091483_001
7NDA020605ZOFRANNOVARTIS PHARMACEUTICALS CORP1997-01-24p5854270, RELIEF OF NAUSEA AND VOMITING, SUBSTANCENDA020605_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076960_001RXONDANSETRON HYDROCHLORIDE (EQ 4MG BASE/5ML)ORALSOLUTIONFalseAA2006-12-26ONDANSETRON HYDROCHLORIDE
2ANDA077009_001RXONDANSETRON HYDROCHLORIDE (EQ 4MG BASE/5ML)ORALSOLUTIONFalseAA2007-11-30ONDANSETRON HYDROCHLORIDE
3ANDA078127_001RXONDANSETRON HYDROCHLORIDE (EQ 4MG BASE/5ML)ORALSOLUTIONFalseAA2007-06-25ONDANSETRON HYDROCHLORIDE
4ANDA078776_001RXONDANSETRON HYDROCHLORIDE (EQ 4MG BASE/5ML)ORALSOLUTIONFalseAA2007-11-28ONDANSETRON HYDROCHLORIDE
5ANDA091342_001RXONDANSETRON HYDROCHLORIDE (EQ 4MG BASE/5ML)ORALSOLUTIONFalseAA2011-01-27ONDANSETRON HYDROCHLORIDE
6ANDA091483_001RXONDANSETRON HYDROCHLORIDE (EQ 4MG BASE/5ML)ORALSOLUTIONFalseAA2011-01-31ONDANSETRON HYDROCHLORIDE
7NDA020605_001RXONDANSETRON HYDROCHLORIDE (EQ 4MG BASE/5ML)ORALSOLUTIONTrueAA1997-01-24ZOFRAN

patent(s)

#idexpiration dateapplication(s)
1p5854270 (view patent)2015-11-20NDA020605

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
104800a86-2391-44e6-8763-d65e8a916c26 (view SPL)ONDANSETRON ORAL SOLUTION, USPprescriptionHuman PrescriptionPrecision Dose Inc.2015-03-231680940763
21a0c4dc6-643e-4ee7-92a9-edb98049a5ba (view SPL)ONDANSETRON Oral Solution, USPprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-01-309000540064
338435346-d505-4bdd-bbc6-a7bcba411033 (view SPL)Ondansetron Oral Solution, USP 4 mg/5 mLprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2014-10-037651620691
47a3c9566-1847-4867-b528-0e91fb8bab94 (view SPL)Ondansetron Oral Solution, USP 4 MG/5 MLprescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2011-06-102178564091
5a95ca4f4-c4de-4822-9a08-209d10bf5136 (view SPL)Ondansetron Oral Solution USP, 4mg/5mLprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-10-074516724091
6ac3dfb81-a4c7-4147-9374-c234153b7c51 (view SPL)prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-11-066167140671
7b4f49bd9-67e4-37be-f936-28876681f14b (view SPL)Prescribing Information Rx Only Ondansetron Oral Solution, USP 4 mg/5 mLprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-10-184605050381
8c7d61d98-fe86-4340-9b86-47eb92acaa0e (view SPL)ZOFRAN (ondansetron hydrochloride) Tablets ZOFRAN ODT (ondansetron) Orally Disintegrating Tablets ZOFRAN (ondansetron hydrochloride) Oral SolutionprescriptionHuman PrescriptionGlaxosmithkline Llc2014-10-0115001730489, 001730446, 001730447, 001730569, 001730570Ondansetron Disintegrating Oral Tablet
Ondansetron Oral Tablet
9cf10d256-dd89-4a91-a3ed-81db505a79c2 (view SPL)Ondansetron Oral Solution, USPRx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-10-019658620208
10ddbeb79e-90d4-4c83-9b69-e7915867edbe (view SPL)ONDANSETRON ORAL SOLUTION USPprescriptionHuman PrescriptionPrecision Dose Inc.2012-02-212680940325
11e5ab38a2-5921-4320-a313-e0080c078046 (view SPL)Ondansetron Oral Solution, USP 4 MG/5 MLprescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2011-06-102178560691
12e6c549a7-774f-4274-9bc5-1149fed5c526 (view SPL)Ondansetron Oral Solution, USPprescriptionHuman PrescriptionSilarx Pharmaceuticals, Inc2015-01-2311548380555

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