p-Hydroxyamphetamine / Tropicamide Ophthalmic Solution

Brand(s)
Paremyd
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2012-08-30)
Oldest Current Product
1992-01-30
License(s)
NDA
RxNORM
OPHTHALMIC SOLUTION\P-HYDROXYAMPHETAMINE:TROPICAMIDE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\HYDROXYAMPHETAMINE HYDROBROMIDE: TROPICAMIDE
SPL Active
OPHTHALMIC\SOLUTION\HYDROXYAMPHETAMINE HYDROBROMIDE: TROPICAMIDE
SPL Moiety
OPHTHALMIC\SOLUTION\HYDROXYAMPHETAMINE: TROPICAMIDE

product(s) by strength(s)

p-hydroxyamphetamine 10 mg/ml / tropicamide 2.5 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780704ParemydNDAAkorn1992-01-30HYDROXYAMPHETAMINE HYDROBROMIDE, TROPICAMIDEOPHTHALMICSOLUTIONNDA019261da8a8a19-ac1b-4160-aac4-c4c57598eb5d

application(s)

#idtitleapplicantapprovedapproved drug
1NDA019261PAREMYDAKORN INC1992-01-30NDA019261_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA019261_001RXHYDROXYAMPHETAMINE HYDROBROMIDE (1%), TROPICAMIDE (0.25%)OPHTHALMICSOLUTION/DROPSTrue1992-01-30PAREMYD

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1da8a8a19-ac1b-4160-aac4-c4c57598eb5d (view SPL)PAREMYDprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-08-302174780704

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