Chlorpheniramine / Hydrocodone Oral Solution

Brand(s)
Vituz
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hawthorn Pharmaceutical, Inc. (2014-09-29)
Oldest Current Product
2013-04-01
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\CHLORPHENIRAMINE:HYDROCODONE
FDAOB
ORAL\SOLUTION\CHLORPHENIRAMINE MALEATE: HYDROCODONE BITARTRATE
SPL Active
ORAL\SOLUTION\CHLORPHENIRAMINE MALEATE: HYDROCODONE BITARTRATE
SPL Moiety
ORAL\SOLUTION\CHLORPHENIRAMINE: HYDROCODONE

product(s) by strength(s)

chlorpheniramine maleate 0.8 mg/ml / hydrocodone bitartrate 1 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1637170877VituzNDAHawthorn Pharmaceutical, Inc.2013-04-01CHLORPHENIRAMINE MALEATE, HYDROCODONE BITARTRATEORALSOLUTIONNDA20430735ecdec3-4a59-479f-a3cb-4ffe0d4ab85e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1278080104ANDATris Pharma Inc2015-03-01CHLORPHENIRAMINE MALEATE, HYDROCODONE BITARTRATEORALSOLUTIONANDA20643847dae0e8-065f-4722-a1c1-4763e25e14d4

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA206438HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATETRIS PHARMA INC2015-01-27ANDA206438_001
2NDA204307VITUZCYPRESS PHARMACEUTICAL INC2013-02-20NDA204307_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA206438_001RXCHLORPHENIRAMINE MALEATE (4MG/5ML), HYDROCODONE BITARTRATE (5MG/5ML)ORALSOLUTIONFalseAA2015-01-27HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE
2NDA204307_001RXHYDROCODONE BITARTRATE (5MG/5ML), CHLORPHENIRAMINE MALEATE (4MG/5ML)ORALSOLUTIONTrueAA2013-02-20VITUZ

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
135ecdec3-4a59-479f-a3cb-4ffe0d4ab85e (view SPL)These highlights do not include all the information needed to use VITUZ safely and effectively. See full prescribing information for VITUZ. VITUZ (hydrocodone bitartrate and chlorpheniramine maleate) Oral Solution, CII. Initial U.S. Approval: 1987prescriptionHuman PrescriptionHawthorn Pharmaceutical, Inc.2014-09-292637170877
247dae0e8-065f-4722-a1c1-4763e25e14d4 (view SPL)These highlights do not include all the information needed to use Hydrocodone Bitartrate and Chlorpheniramine Maleate Oral Solution safely and effectively. See full prescribing information for Hydrocodone Bitartrate and Chlorpheniramine Maleate Oral Solution. CII Hydrocodone Bitartrate and Chlorpheniramine Maleate Solution, for oral use Initial U.S. Approval: [1987]prescriptionHuman PrescriptionTris Pharma IncANALYSIS, MANUFACTURE2015-02-263278080104

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