Guaifenesin / Hydrocodone Oral Solution

Brand(s)
Flowtuss, Obredon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mission Pharmacal Company (2015-08-18)
Oldest Current Product
2015-08-18
License(s)
NDA
RxNORM
ORAL SOLUTION\GUAIFENESIN:HYDROCODONE
FDAOB
ORAL\SOLUTION\GUAIFENESIN: HYDROCODONE BITARTRATE
SPL Active
ORAL\LIQUID\GUAIFENESIN: HYDROCODONE BITARTRATE
SPL Moiety
ORAL\LIQUID\GUAIFENESIN: HYDROCODONE

product(s) by strength(s)

guaifenesin 40 mg/ml / hydrocodone bitartrate 0.5 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001783482FlowtussNDAMission Pharmacal Company2015-08-18GUAIFENESIN, HYDROCODONE BITARTRATEORALLIQUIDNDA0224241d0c2c03-ca11-30b1-e054-00144ff8d46c

application(s)

#idtitleapplicantapprovedapproved drug
1NDA022424FLOWTUSSMISSION PHARMACAL CO2015-05-14NDA022424_001
2NDA205474OBREDONSOVEREIGN PHARMACEUTICALS LLC2014-11-14NDA205474_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022424_001RXHYDROCODONE BITARTRATE (2.5MG/5ML), GUAIFENESIN (200MG/5ML)ORALSOLUTIONFalse2015-05-14FLOWTUSS
2NDA205474_001RXHYDROCODONE BITARTRATE (2.5MG/5ML), GUAIFENESIN (200MG/5ML)ORALSOLUTIONTrue2014-11-14OBREDON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11d0c2c03-ca11-30b1-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use FLOWTUSS safely and effectively. See full prescribing information for FLOWTUSS. FLOWTUSS (hydrocodone bitartrate and guaifenesin) oral solution, CII Initial U.S. Approval: 2014prescriptionHuman PrescriptionMission Pharmacal Company2015-08-182001783482
231c14c1c-a250-4891-b6ab-9c5961fc8a39 (view SPL)These highlights do not include all the information needed to use OBREDON (hydrocodone bitartrate and guaifenesin) Oral Solution safely and effectively. See full prescribing information for OBREDON (hydrocodone bitartrate and guaifenesin) Oral Solution. OBREDON (hydrocodone bitartrate and guaifenesin) Oral Solution for oral administration CII Initial U.S. Approval: 2014prescriptionHuman PrescriptionNovotec Pharma Llcmanufacture2015-06-222691660523

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