Chlorpheniramine Extended Release Oral Tablet

Brand(s)
Chlor-Trimeton
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Msd Consumer Care, Inc. (2010-05-26)
Oldest Current Product
2010-01-04
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\CHLORPHENIRAMINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\CHLORPHENIRAMINE MALEATE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\CHLORPHENIRAMINE MALEATE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\CHLORPHENIRAMINE MALEATE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\CHLORPHENIRAMINE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\CHLORPHENIRAMINE

product(s) by strength(s)

12 hr chlorpheniramine maleate 12 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1115230728Chlor-TrimetonNDAMsd Consumer Care, Inc.2010-01-04CHLORPHENIRAMINE MALEATEORALTABLET, EXTENDED RELEASENDA007638ba907153-2639-485b-abd8-af239eccd4ed

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1107020017ANDAKvk-Tech, Inc.2010-06-15CHLORPHENIRAMINE MALEATEORALTABLET, FILM COATED, EXTENDED RELEASEANDA04082984409269-fe9b-469e-9a66-27b1475231a3
2372050117ANDACardinal Health2010-12-20CHLORPHENIRAMINE MALEATEORALTABLET, FILM COATED, EXTENDED RELEASEANDA040829cade2f27-fc17-4538-bcdc-67bafd85371d

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040829CHLORPHENIRAMINE MALEATEAVANTHI INC2009-05-13ANDA040829_001
2NDA007638CHLOR-TRIMETONBAYER HEALTHCARE LLCNDA007638_001, NDA007638_002
3NDA019746EFIDAC 24 CHLORPHENIRAMINE MALEATETrueALZA CORP1994-11-18NDA019746_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040829_001OTCCHLORPHENIRAMINE MALEATE (12MG)ORALTABLET, EXTENDED RELEASEFalse2009-05-13CHLORPHENIRAMINE MALEATE
2NDA007638_001discontinuedCHLORPHENIRAMINE MALEATE (8MG)ORALTABLET, EXTENDED RELEASEFalseCHLOR-TRIMETON
3NDA007638_002OTCCHLORPHENIRAMINE MALEATE (12MG)ORALTABLET, EXTENDED RELEASETrueCHLOR-TRIMETON
4NDA019746_002discontinuedCHLORPHENIRAMINE MALEATE (16MG)ORALTABLET, EXTENDED RELEASEFalse1994-11-18EFIDAC 24 CHLORPHENIRAMINE MALEATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
184409269-fe9b-469e-9a66-27b1475231a3 (view SPL)Unknown TitleotcHuman OTCKvk-Tech, Inc.MANUFACTURE2012-08-301107020017
2ba907153-2639-485b-abd8-af239eccd4ed (view SPL)Chlor-TrimetonotcHuman OTCMsd Consumer Care, Inc.MANUFACTURE2010-05-262115230728
3cade2f27-fc17-4538-bcdc-67bafd85371d (view SPL)Unknown TitleotcHuman OTCCardinal HealthMANUFACTURE2012-08-301372050117

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