Atropine / Diphenoxylate Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2012-08-01)
Oldest Current Product
1982-05-03
License(s)
ANDA
RxNORM
ORAL SOLUTION\ATROPINE:DIPHENOXYLATE
FDAOB
ORAL\SOLUTION\ATROPINE SULFATE: DIPHENOXYLATE HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\ATROPINE SULFATE: DIPHENOXYLATE HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\ATROPINE: DIPHENOXYLATE

product(s) by strength(s)

atropine sulfate 0.005 mg/ml / diphenoxylate hydrochloride 0.5 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543194ANDARoxane Laboratories, Inc1982-05-03ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDEORALSOLUTIONANDA08770888ed4ccf-9e35-4142-a5eb-d2b5edd36956

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA085735COLONAIDTrueMEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INCANDA085735_001
2ANDA085746LOMANATETrueALPHARMA US PHARMACEUTICALS DIVISIONANDA085746_001
3ANDA087708DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEROXANE LABORATORIES INC1982-05-03ANDA087708_001
4NDA012699LOMOTILTrueGD SEARLE LLCNDA012699_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA085735_001discontinuedATROPINE SULFATE (0.025MG/5ML), DIPHENOXYLATE HYDROCHLORIDE (2.5MG/5ML)ORALSOLUTIONFalseCOLONAID
2ANDA085746_001discontinuedATROPINE SULFATE (0.025MG/5ML), DIPHENOXYLATE HYDROCHLORIDE (2.5MG/5ML)ORALSOLUTIONFalseLOMANATE
3ANDA087708_001RXATROPINE SULFATE (0.025MG/5ML), DIPHENOXYLATE HYDROCHLORIDE (2.5MG/5ML)ORALSOLUTIONTrueAA1982-05-03DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
4NDA012699_001discontinuedATROPINE SULFATE (0.025MG/5ML), DIPHENOXYLATE HYDROCHLORIDE (2.5MG/5ML)ORALSOLUTIONFalseLOMOTIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
188ed4ccf-9e35-4142-a5eb-d2b5edd36956 (view SPL)DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE Oral Solution, USP CVprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-08-013000543194

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