Chlorpheniramine / Hydrocodone / Pseudoephedrine Oral Solution

Brand(s)
Zutripro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cypress Pharmaceutical, Inc. (2014-09-30)
Oldest Current Product
2014-01-09
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\CHLORPHENIRAMINE:HYDROCODONE:PSEUDOEPHEDRINE
FDAOB
ORAL\SOLUTION\CHLORPHENIRAMINE MALEATE: HYDROCODONE BITARTRATE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\CHLORPHENIRAMINE MALEATE: HYDROCODONE BITARTRATE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\CHLORPHENIRAMINE: HYDROCODONE: PSEUDOEPHEDRINE

product(s) by strength(s)

chlorpheniramine maleate 0.8 mg/ml / hydrocodone bitartrate 1 mg/ml / pseudoephedrine hydrochloride 12 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1602580876NDACypress Pharmaceutical, Inc.2014-01-09CHLORPHENIRAMINE MALEATE, HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSOLUTIONNDA02243931a81b1f-f936-4853-a331-e0a45c3466cb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005741103ANDAPaddock Laboratories, Llc2014-08-26CHLORPHENIRAMINE MALEATE, HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSOLUTIONANDA2046275ab09c98-cb39-43be-b306-5eff3c31b563
2278080087ANDATris Pharma Inc2015-01-04CHLORPHENIRAMINE MALEATE, HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSOLUTIONANDA203838a29a740d-ee23-459b-804a-891022702bc3

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA203838HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDETRIS PHARMA INC2014-11-26ANDA203838_001
2ANDA204627HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE PADDOCK LABORATORIES LLC2014-04-29ANDA204627_001
3ANDA205657HYDROCODONE BITARTRATE,CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDECOASTAL PHARMACEUTICALS2015-08-03ANDA205657_001
4NDA022439ZUTRIPROCYPRESS PHARMACEUTICAL INC2011-06-08NDA022439_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203838_001RXHYDROCODONE BITARTRATE (5MG/5ML), PSEUDOEPHEDRINE HYDROCHLORIDE (60MG/5ML), CHLORPHENIRAMINE MALEATE (4MG/5ML)ORALSOLUTIONFalseAA2014-11-26HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
2ANDA204627_001RXHYDROCODONE BITARTRATE (5MG/5ML), CHLORPHENIRAMINE MALEATE (4MG/5ML), PSEUDOEPHEDRINE HYDROCHLORIDE (60MG/5ML)ORALSOLUTIONFalseAA2014-04-29HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
3ANDA205657_001RXCHLORPHENIRAMINE MALEATE (4MG/5ML), PSEUDOEPHEDRINE HYDROCHLORIDE (60MG/5ML), HYDROCODONE BITARTRATE (5MG/5ML)ORALSOLUTIONFalseAA2015-08-03HYDROCODONE BITARTRATE,CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
4NDA022439_001RXHYDROCODONE BITARTRATE (5MG/5ML), PSEUDOEPHEDRINE HYDROCHLORIDE (60MG/5ML), CHLORPHENIRAMINE MALEATE (4MG/5ML)ORALSOLUTIONTrueAA2011-06-08ZUTRIPRO

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
131a81b1f-f936-4853-a331-e0a45c3466cb (view SPL)These highlights do not include all the information needed to use Hydrocodone Bitartrate, Pseudoephedrine HCl, and Chlorpheniramine Maleate Oral Solution safely and effectively. See full prescribing information for Hydrocodone Bitartrate, Pseudoephedrine HCl, and Chlorpheniramine Maleate Oral Solution. Hydrocodone Bitartrate, Pseudoephedrine HCl, and Chlorpheniramine Maleate Oral Solution, CIIInitial U.S. Approval: 2011prescriptionHuman PrescriptionCypress Pharmaceutical, Inc.2014-09-303602580876
25ab09c98-cb39-43be-b306-5eff3c31b563 (view SPL)These highlights do not include all the information needed to use Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Oral Solution safely and effectively. See full prescribing information for Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Oral Solution.Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Oral Solution, CIIInitial U.S. Approval: 2011prescriptionHuman PrescriptionPaddock Laboratories, Llc2014-11-063005741103
36b6ab0f8-fbe6-41f3-9af4-2c86cec4eaf7 (view SPL)These highlights do not include all the information needed to use ZUTRIPRO Oral Solution safely and effectively. See full prescribing information for ZUTRIPRO Oral Solution. ZUTRIPRO (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride) Oral Solution, CIIInitial U.S. Approval: 2011prescriptionHuman PrescriptionHawthorn Pharmaceutical, Inc.2014-09-304637170876
4a29a740d-ee23-459b-804a-891022702bc3 (view SPL)These highlights do not include all the information needed to use Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride Oral Solution safely and effectively. See full prescribing information for Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride Oral Solution CII. Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride Oral Solution,for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionTris Pharma Inc2014-12-302278080087

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