Hydrocodone / Pseudoephedrine Oral Solution

Brand(s)
Rezira
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hawthorn Pharmaceutical, Inc. (2014-09-29)
Oldest Current Product
2011-06-08
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\HYDROCODONE:PSEUDOEPHEDRINE
FDAOB
ORAL\SOLUTION\HYDROCODONE BITARTRATE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\HYDROCODONE BITARTRATE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\HYDROCODONE: PSEUDOEPHEDRINE

product(s) by strength(s)

hydrocodone bitartrate 1 mg/ml / pseudoephedrine hydrochloride 12 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1637170875ReziraNDAHawthorn Pharmaceutical, Inc.2011-06-08HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSOLUTIONNDA0224427b873615-d90e-41a1-acc6-60f0526eeead

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1278080088ANDATris Pharma Inc2014-12-31HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSOLUTIONANDA203839d8344453-c7c0-4e4b-aab7-8447ef28322a

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA203839HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDETRIS PHARMA INC2014-10-28ANDA203839_001
2ANDA204658HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDEPADDOCK LABORATORIES LLC2014-04-29ANDA204658_001
3NDA022442REZIRACYPRESS PHARMACEUTICAL INC2011-06-08NDA022442_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203839_001RXPSEUDOEPHEDRINE HYDROCHLORIDE (60MG/5ML), HYDROCODONE BITARTRATE (5MG/5ML)ORALSOLUTIONFalseAA2014-10-28HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
2ANDA204658_001RXPSEUDOEPHEDRINE HYDROCHLORIDE (60MG/5ML), HYDROCODONE BITARTRATE (5MG/5ML)ORALSOLUTIONFalseAA2014-04-29HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
3NDA022442_001RXPSEUDOEPHEDRINE HYDROCHLORIDE (60MG/5ML), HYDROCODONE BITARTRATE (5MG/5ML)ORALSOLUTIONTrueAA2011-06-08REZIRA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17b873615-d90e-41a1-acc6-60f0526eeead (view SPL)These highlights do not include all the information needed to use REZIRA Oral Solution safely and effectively. See full prescribing information for REZIRA Oral Solution. CII REZIRA (hydrocodone bitartrate and pseudoephedrine hydrochloride) Oral Solution Initial U.S. Approval: 2011prescriptionHuman PrescriptionHawthorn Pharmaceutical, Inc.2014-09-294637170875
2d8344453-c7c0-4e4b-aab7-8447ef28322a (view SPL)These highlights do not include all the information needed to use Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride Oral Solution safely and effectively. See full prescribing information for Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride Oral Solution. Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride Oral Solution, for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionTris Pharma IncANALYSIS, MANUFACTURE2014-11-042278080088

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