Gentamicin Sulfate (USP) / prednisolone Ophthalmic Ointment

Brand(s)
Pred-G
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Allergan, Inc. (2012-04-11)
Oldest Current Product
1990-01-01
License(s)
NDA
RxNORM
OPHTHALMIC OINTMENT\GENTAMICIN SULFATE (USP):PREDNISOLONE
FDAOB
OPHTHALMIC\OINTMENT\GENTAMICIN SULFATE: PREDNISOLONE ACETATE
SPL Active
OPHTHALMIC\OINTMENT\GENTAMICIN SULFATE: PREDNISOLONE ACETATE
SPL Moiety
OPHTHALMIC\OINTMENT\GENTAMICIN: PREDNISOLONE

product(s) by strength(s)

gentamicin sulfate (usp) 0.003 mg/mg / prednisolone 0.006 mg/mg ophthalmic ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000230066Pred-GNDAAllergan, Inc.1990-01-01GENTAMICIN SULFATE, PREDNISOLONE ACETATEOPHTHALMICOINTMENTNDA050612a76fce5c-81b4-4fa6-904b-34c2313a0828

application(s)

#idtitleapplicantapprovedapproved drug
1NDA050612PRED-GALLERGAN PHARMACEUTICAL1989-12-01NDA050612_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA050612_001RXPREDNISOLONE ACETATE (0.6%), GENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICOINTMENTTrue1989-12-01PRED-G

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a76fce5c-81b4-4fa6-904b-34c2313a0828 (view SPL)PRED-G (gentamicin and prednisolone acetate ophthalmic ointment, USP) 0.3%/0.6%prescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2012-04-113000230066

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