Dexamethasone Ophthalmic Suspension

Brand(s)
Maxidex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-08-05)
Oldest Current Product
1966-05-15
License(s)
NDA
RxNORM
OPHTHALMIC SUSPENSION\DEXAMETHASONE
FDAOB
OPHTHALMIC\SUSPENSION_DROPS\DEXAMETHASONE
SPL Active
OPHTHALMIC\SUSPENSION/DROPS\DEXAMETHASONE
SPL Moiety
OPHTHALMIC\SUSPENSION/DROPS\DEXAMETHASONE

product(s) by strength(s)

dexamethasone 1 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009980615MaxidexNDAAlcon Laboratories, Inc.1966-05-15DEXAMETHASONEOPHTHALMICSUSPENSION/DROPSNDA013422ecd69437-dd1a-453b-991d-5c5f277a3abd

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA089170DEXAMETHASONETrueWATSON LABORATORIES INC1989-05-09ANDA089170_001
2NDA013422MAXIDEXALCON LABORATORIES INCNDA013422_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA089170_001discontinuedDEXAMETHASONE (0.1%)OPHTHALMICSUSPENSION/DROPSFalse1989-05-09DEXAMETHASONE
2NDA013422_001RXDEXAMETHASONE (0.1%)OPHTHALMICSUSPENSION/DROPSTrueMAXIDEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1ecd69437-dd1a-453b-991d-5c5f277a3abd (view SPL)Maxidex 0.1% (dexamethasone ophthalmic suspension) SterileprescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-08-052009980615

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