Ibuprofen / Pseudoephedrine Oral Suspension

Brand(s)
Advil Children's Cold
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Pfizer Consumer Healthcare (2010-06-30)
Oldest Current Product
1989-04-15
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\IBUPROFEN:PSEUDOEPHEDRINE
FDAOB
ORAL\SUSPENSION\IBUPROFEN: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\SUSPENSION\IBUPROFEN: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\SUSPENSION\IBUPROFEN: PSEUDOEPHEDRINE

product(s) by strength(s)

ibuprofen 20 mg/ml / pseudoephedrine hydrochloride 3 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005730187Advil Children's ColdNDAPfizer Consumer Healthcare2002-04-18IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALSUSPENSIONNDA021373f63d1eb1-b51d-de3f-faea-6c4d4b0069c3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1243850549ANDAGood Neighbor Pharmacy1989-04-15IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALSUSPENSIONANDA076478224ea181-4beb-4102-a263-31c9a4c84cdf
2372050399ANDACardinal Health2004-03-25IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALSUSPENSIONANDA076478b6c844c4-4ba6-4827-8db8-5f3f5e99b0c2
3412500180ANDAMeijer Distribution, Inc2004-02-04IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALSUSPENSIONANDA076478d8c84622-e594-4cb8-bf6f-40510029a2dd
4597790180ANDACvs2004-02-12IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALSUSPENSIONANDA0764783a667c4c-b67a-4db7-a5dc-0a6199b435c7

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076478IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEL PERRIGO CO2003-11-05ANDA076478_001
2NDA021128CHILDREN'S MOTRIN COLDJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION2000-08-01p6211246NDA021128_001
3NDA021373CHILDREN'S ADVIL COLDPFIZER INC2002-04-18NDA021373_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA076478_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (15MG/5ML), IBUPROFEN (100MG/5ML)ORALSUSPENSIONFalse2003-11-05IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
2NDA021128_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (15MG/5ML), IBUPROFEN (100MG/5ML)ORALSUSPENSIONTrue2000-08-01CHILDREN'S MOTRIN COLD
3NDA021373_001OTCIBUPROFEN (100MG/5ML), PSEUDOEPHEDRINE HYDROCHLORIDE (15MG/5ML)ORALSUSPENSIONFalse2002-04-18CHILDREN'S ADVIL COLD

patent(s)

#idexpiration dateapplication(s)
1p6211246 (view patent)2019-06-10NDA021128

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1224ea181-4beb-4102-a263-31c9a4c84cdf (view SPL)Amerisource Bergen Children's Ibuprofen Cold Drug FactsotcHuman OTCGood Neighbor Pharmacy2011-09-191243850549
23a667c4c-b67a-4db7-a5dc-0a6199b435c7 (view SPL)CVS Pharmacy, Inc. Ibuprofen Cold Relief Drug FactsotcHuman OTCCvs2009-07-091597790180
3b6c844c4-4ba6-4827-8db8-5f3f5e99b0c2 (view SPL)Cardinal Health Ibuprofen Cold Drug FactsotcHuman OTCCardinal Health2009-07-091372050399
4d8c84622-e594-4cb8-bf6f-40510029a2dd (view SPL)Meijer Distribution, Inc. Ibuprofen Cold Drug FactsotcHuman OTCMeijer Distribution, Inc2009-07-091412500180
5f63d1eb1-b51d-de3f-faea-6c4d4b0069c3 (view SPL)Childrens Advil Cold(ibuprofen and pseudoephedrine HCl)otcHuman OTCPfizer Consumer HealthcareANALYSIS, MANUFACTURE2010-06-303005730187

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