Dicyclomine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Qualitest Pharmaceuticals (2012-12-10)
Oldest Current Product
2005-06-23
License(s)
ANDA
RxNORM
ORAL SOLUTION\DICYCLOMINE
FDAOB
ORAL\SYRUP\DICYCLOMINE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\DICYCLOMINE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\DICYCLOMINE

product(s) by strength(s)

dicyclomine hydrochloride 2 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006031161ANDAQualitest Pharmaceuticals2005-06-23DICYCLOMINE HYDROCHLORIDEORALSOLUTIONANDA040169bb099db9-f635-4a64-8892-6236971dec45

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790173ANDAKaiser Foundations Hospitals2015-04-02DICYCLOMINE HYDROCHLORIDEORALSOLUTION006031161ANDA040169003ef38b-8c59-4930-8d1f-b76153fddbb6
2178561161ANDAAtlantic Biologicals Corps2005-06-23DICYCLOMINE HYDROCHLORIDEORALSOLUTION006031161ANDA04016995a0f538-4c94-487a-b85f-424eddd59459

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040169DICYCLOMINE HYDROCHLORIDEMIKART INC2005-03-24ANDA040169_001
2ANDA084479DICYCLOMINE HYDROCHLORIDETrueALPHARMA US PHARMACEUTICALS DIVISIONANDA084479_001
3NDA007961BENTYLAPTALIS PHARMA US INC1984-10-15NDA007961_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040169_001RXDICYCLOMINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPFalseAA2005-03-24DICYCLOMINE HYDROCHLORIDE
2ANDA084479_001discontinuedDICYCLOMINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPFalseDICYCLOMINE HYDROCHLORIDE
3NDA007961_002RXDICYCLOMINE HYDROCHLORIDE (10MG/5ML)ORALSYRUPTrueAA1984-10-15BENTYL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1003ef38b-8c59-4930-8d1f-b76153fddbb6 (view SPL)prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2015-05-071001790173
295a0f538-4c94-487a-b85f-424eddd59459 (view SPL)prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2012-01-202178561161
3bb099db9-f635-4a64-8892-6236971dec45 (view SPL)prescriptionHuman PrescriptionQualitest Pharmaceuticals2012-12-102006031161

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