dexbrompheniramine / Pseudoephedrine Extended Release Oral Tablet

Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Kvk-Tech, Inc. (2013-02-27)
Oldest Current Product
2013-02-27
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\DEXBROMPHENIRAMINE:PSEUDOEPHEDRINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\DEXBROMPHENIRAMINE MALEATE: PSEUDOEPHEDRINE SULFATE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\DEXBROMPHENIRAMINE MALEATE: PSEUDOEPHEDRINE SULFATE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\DEXBROMPHENIRAMINE: PSEUDOEPHEDRINE

product(s) by strength(s)

12 hr dexbrompheniramine maleate 6 mg / pseudoephedrine sulfate 120 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1107020005ANDAKvk-Tech, Inc.2013-02-27DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE SULFATEORALTABLET, EXTENDED RELEASEANDA078648cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070770DISOBROMTrueSANDOZ INC1991-09-30ANDA070770_001
2ANDA078648DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATEAVANTHI INC2013-02-27ANDA078648_001
3ANDA089116BROMPHERILTrueCOPLEY PHARMACEUTICAL INC1987-01-22ANDA089116_001
4ANDA089139RESPORALTruePIONEER PHARMACEUTICALS INC1988-06-16ANDA089139_001
5NDA013483DISOPHROLTrueSCHERING PLOUGH HEALTHCARE PRODUCTS INC1982-09-13NDA013483_003, NDA013483_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA070770_001discontinuedDEXBROMPHENIRAMINE MALEATE (6MG), PSEUDOEPHEDRINE SULFATE (120MG)ORALTABLET, EXTENDED RELEASEFalse1991-09-30DISOBROM
2ANDA078648_001OTCDEXBROMPHENIRAMINE MALEATE (6MG), PSEUDOEPHEDRINE SULFATE (120MG)ORALTABLET, EXTENDED RELEASETrue2013-02-27DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE
3ANDA089116_001discontinuedPSEUDOEPHEDRINE SULFATE (120MG), DEXBROMPHENIRAMINE MALEATE (6MG)ORALTABLET, EXTENDED RELEASEFalse1987-01-22BROMPHERIL
4ANDA089139_001discontinuedPSEUDOEPHEDRINE SULFATE (120MG), DEXBROMPHENIRAMINE MALEATE (6MG)ORALTABLET, EXTENDED RELEASEFalse1988-06-16RESPORAL
5NDA013483_003discontinuedDEXBROMPHENIRAMINE MALEATE (6MG), PSEUDOEPHEDRINE SULFATE (120MG)ORALTABLET, EXTENDED RELEASEFalse1982-09-13DISOPHROL
6NDA013483_004discontinuedDEXBROMPHENIRAMINE MALEATE (6MG), PSEUDOEPHEDRINE SULFATE (120MG)ORALTABLET, EXTENDED RELEASEFalse1982-09-13DISOPHROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4 (view SPL)Dexbrompheniramine maleate 6 mg Pseudoephedrine Sulfate 120 mgotcHuman OTCKvk-Tech, Inc.MANUFACTURE2013-02-272107020005

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