Oxycodone Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lehigh Valley Technologies, Inc. (2014-11-11)
Oldest Current Product
2010-10-20
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SOLUTION\OXYCODONE
FDAOB
ORAL\SOLUTION\OXYCODONE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION, CONCENTRATE\OXYCODONE HYDROCHLORIDE
ORAL\SOLUTION\OXYCODONE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION, CONCENTRATE\OXYCODONE
ORAL\SOLUTION\OXYCODONE

product(s) by strength(s)

oxycodone hydrochloride 1 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1666890401NDAVistapharm Inc.2012-03-15OXYCODONE HYDROCHLORIDEORALSOLUTIONNDA201194d7dceba3-96dc-4593-bc8f-318052bdb520
2666890403NDAVistapharm Inc.2012-03-15OXYCODONE HYDROCHLORIDEORALSOLUTIONNDA201194d7dceba3-96dc-4593-bc8f-318052bdb520

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000540390ANDARoxane Laboratories, Inc2015-02-02OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA204037d8e87c66-f872-4e1d-9ade-ef11490af63b
2000540523ANDARoxane Laboratories, Inc2013-07-152017-02-04OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA20403772260dc5-08eb-4b91-ae54-c7be35242b70
3604320706ANDAMorton Grove Pharmaceuticals, Inc.2015-06-17OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA20645673eb3e1f-7706-4688-9e75-1050b4a8a533
4625590151ANDAAnip Acquisition Company2015-10-13OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA204979819ed9fc-0a21-4ed0-9080-91912c5f8ce2

oxycodone hydrochloride 20 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1649500353NDALehigh Valley Technologies, Inc.2010-10-20OXYCODONE HYDROCHLORIDEORALSOLUTIONNDA2005356869fec9-1837-4221-afd8-5cc6fadd025d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540393ANDARoxane Laboratories, Inc2015-01-01OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA2032084a0d2daf-beeb-4ada-8aad-bcb813e8b04a
2000540522ANDARoxane Laboratories, Inc2013-07-16OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA20320875a36759-c970-4689-b373-a6a15b6a1a3c
3005271426ANDALannett Company, Inc.2014-09-10OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA204085d46fcd26-a828-4b9f-af88-1f62a7cb9598
4400320920ANDANovel Laboratories, Inc.2015-04-29OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA204603fb100a73-a655-44e9-9985-d2d7efe5b49b
5433860920ANDAGavis Pharmaceuticals, Llc2015-07-01OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA2046033eddd18b-695a-4e53-a76c-f6779515b918
6666890025ANDAVistapharm Inc.2012-08-15OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA2025377c686a46-1f5f-46e3-945b-2ade3931718f
7683080020ANDAMayne Pharma Inc.2014-06-12OXYCODONE HYDROCHLORIDEORALSOLUTIONANDA2040926fcb8041-c9c7-4a31-8f1a-35e54d33f46f
8684620347NDA AUTHORIZED GENERICGlenmark Generics Inc., Usa2010-12-20OXYCODONE HYDROCHLORIDEORALSOLUTIONNDA2005357290eb06-641a-43df-9a23-74288ca1e25d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1484330347NDA AUTHORIZED GENERICSafecor Health, Llc2013-09-23OXYCODONE HYDROCHLORIDEORALSOLUTION, CONCENTRATE684620347NDA200535c0d7293d-5203-4fbe-b944-3960810cb24c

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA202537OXYCODONE HYDROCHLORIDEVISTAPHARM INC2012-07-30ANDA202537_001
2ANDA203208OXYCODONE HYDROCHLORIDEROXANE LABORATORIES INC2013-07-12ANDA203208_001
3ANDA204037OXYCODONE HYDROCHLORIDEROXANE LABORATORIES INC2013-07-15ANDA204037_001
4ANDA204085OXYCODONE HYDROCHLORIDELANNETT HOLDINGS INC2014-09-09ANDA204085_001
5ANDA204092OXYCODONE HYDROCHLORIDECOASTAL PHARMACEUTICALS2014-06-05ANDA204092_001
6ANDA204603OXYCODONE HYDROCHLORIDENOVEL LABORATORIES INC2015-04-29ANDA204603_001
7ANDA204979OXYCODONE HYDROCHLORIDEANI PHARMACEUTICALS INC2015-06-01ANDA204979_001
8ANDA206456OXYCODONE HYDROCHLORIDEWOCKHARDT BIO AG2015-06-16ANDA206456_001
9NDA200535OXYCODONE HYDROCHLORIDELEHIGH VALLEY TECHNOLOGIES INC2010-10-20NDA200535_001, NDA200535_002
10NDA201194OXYCODONE HYDROCHLORIDEVISTAPHARM INC2012-01-12NDA201194_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA202537_001RXOXYCODONE HYDROCHLORIDE (100MG/5ML)ORALSOLUTIONFalseAA2012-07-30OXYCODONE HYDROCHLORIDE
2ANDA203208_001RXOXYCODONE HYDROCHLORIDE (100MG/5ML)ORALSOLUTIONFalseAA2013-07-12OXYCODONE HYDROCHLORIDE
3ANDA204037_001RXOXYCODONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONFalseAA2013-07-15OXYCODONE HYDROCHLORIDE
4ANDA204085_001RXOXYCODONE HYDROCHLORIDE (100MG/5ML)ORALSOLUTIONFalseAA2014-09-09OXYCODONE HYDROCHLORIDE
5ANDA204092_001RXOXYCODONE HYDROCHLORIDE (100MG/5ML)ORALSOLUTIONFalseAA2014-06-05OXYCODONE HYDROCHLORIDE
6ANDA204603_001RXOXYCODONE HYDROCHLORIDE (100MG/5ML)ORALSOLUTIONFalseAA2015-04-29OXYCODONE HYDROCHLORIDE
7ANDA204979_001RXOXYCODONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONFalseAA2015-06-01OXYCODONE HYDROCHLORIDE
8ANDA206456_001RXOXYCODONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONFalseAA2015-06-16OXYCODONE HYDROCHLORIDE
9NDA200535_001RXOXYCODONE HYDROCHLORIDE (100MG/5ML)ORALSOLUTIONTrueAA2010-10-20OXYCODONE HYDROCHLORIDE
10NDA200535_002RXOXYCODONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONFalseAA2013-08-22OXYCODONE HYDROCHLORIDE
11NDA201194_001RXOXYCODONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONTrueAA2012-01-12OXYCODONE HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13eddd18b-695a-4e53-a76c-f6779515b918 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride safely and effectively. See full prescribing information for Oxycodone Hydrochloride. Oxycodone Hydrochloride (Oxycodone Hydrochloride) SOLUTION for ORAL use.Initial U.S. Approval: 1950prescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2015-08-312433860920
24a0d2daf-beeb-4ada-8aad-bcb813e8b04a (view SPL)These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Oral Solution USP safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE Oral Solution USP. OXYCODONE HYDROCHLORIDE Oral Solution USP, for oral use, CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2013-03-081000540393
36869fec9-1837-4221-afd8-5cc6fadd025d (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution.Oxycodone Hydrochloride Oral Solution CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionLehigh Valley Technologies, Inc.MANUFACTURE2014-11-1111649500353, 649500354
46fcb8041-c9c7-4a31-8f1a-35e54d33f46f (view SPL)These highlights do not include all the information needed to use oxycodone hydrochloride oral solution safely and effectively. See full prescribing information for oxycodone hydrochloride oral solution. OXYCODONE hydrochloride oral solution, USP, for oral use CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionMayne Pharma Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-093683080020
572260dc5-08eb-4b91-ae54-c7be35242b70 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution USP. OXYCODONE HYDROCHLORIDE ORAL SOLUTION USP, for oral use, CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-02-044000540523
67290eb06-641a-43df-9a23-74288ca1e25d (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution. Oxycodone Hydrochloride Oral Solution CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionGlenmark Generics Inc., Usa2011-01-111684620347
773eb3e1f-7706-4688-9e75-1050b4a8a533 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution, USP.Oxycodone Hydrochloride Oral Solution, USP CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.Analysis, Label, Manufacture, Pack2015-06-261604320706
875a36759-c970-4689-b373-a6a15b6a1a3c (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution USP. Initial U.S. Approval: 1950prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2013-03-112000540522
97c686a46-1f5f-46e3-945b-2ade3931718f (view SPL)These highlights do not include all the information needed to use oxycodone hydrochloride oral solution safely and effectively. See full prescribing information for oxycodone hydrochloride oral solution. Oxycodone hydrochloride oral solution, C-II Initial U.S. Approval: 1950prescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE2012-08-111666890025
10819ed9fc-0a21-4ed0-9080-91912c5f8ce2 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution. OXYCODONE Hydrochloride Oral Solution USP for oral use, CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionAnip Acquisition CompanyANALYSIS, LABEL, MANUFACTURE, PACK2015-10-131625590151
11c0d7293d-5203-4fbe-b944-3960810cb24c (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution. Oxycodone Hydrochloride Oral Solution CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionSafecor Health, Llcrepack2014-01-175484330347
12d46fcd26-a828-4b9f-af88-1f62a7cb9598 (view SPL)These highlights do not include all the information needed to useoxycodone hydrochloride oral solutionsafely and effectively. See full prescribing information for oxycodone hydrochloride oral solution. OXYCODONE Hydrochloride Oral Solution USP, for oral use,CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-09-1620005271426
13d7dceba3-96dc-4593-bc8f-318052bdb520 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution. Oxycodone Hydrochloride Oral Solution CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE2012-03-051666890401, 666890403
14d8e87c66-f872-4e1d-9ade-ef11490af63b (view SPL)These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Oral Solution USP safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE Oral Solution USP. OXYCODONE HYDROCHLORIDE Oral Solution USP, for oral use, CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-01-301000540390
15fb100a73-a655-44e9-9985-d2d7efe5b49b (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride safely and effectively. See full prescribing information for Oxycodone Hydrochloride. Oxycodone Hydrochloride (Oxycodone Hydrochloride) SOLUTION for ORAL use.Initial U.S. Approval: 1950prescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2015-05-144400320920

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