Dexamethasone / Tobramycin Ophthalmic Ointment

Brand(s)
Tobradex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-07-18)
Oldest Current Product
1988-09-28
License(s)
NDA
RxNORM
OPHTHALMIC OINTMENT\DEXAMETHASONE:TOBRAMYCIN
FDAOB
OPHTHALMIC\OINTMENT\DEXAMETHASONE: TOBRAMYCIN
SPL Active
OPHTHALMIC\OINTMENT\DEXAMETHASONE: TOBRAMYCIN
SPL Moiety
OPHTHALMIC\OINTMENT\DEXAMETHASONE: TOBRAMYCIN

product(s) by strength(s)

dexamethasone 0.001 mg/mg / tobramycin 0.003 mg/mg ophthalmic ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000650648TobradexNDAAlcon Laboratories, Inc.1988-10-15DEXAMETHASONE, TOBRAMYCINOPHTHALMICOINTMENTNDA0506165538d748-215c-4e3e-b940-ac9baf07d8a1

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950628TobradexNDARebel Distributors Corp1988-09-28DEXAMETHASONE, TOBRAMYCINOPHTHALMICOINTMENT000650648NDA050616fe08bcd5-4d14-4c2d-940c-b7968f9a89f0
2545692590TobradexNDAA-S Medication Solutions Llc1988-10-15DEXAMETHASONE, TOBRAMYCINOPHTHALMICOINTMENT000650648NDA0506161b6887e4-9deb-494a-939d-49ce77ef2c1b

application(s)

#idtitleapplicantapprovedapproved drug
1NDA050616TOBRADEXALCON LABORATORIES INC1988-09-28NDA050616_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA050616_001RXTOBRAMYCIN (0.3%), DEXAMETHASONE (0.1%)OPHTHALMICOINTMENTTrue1988-09-28TOBRADEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11b6887e4-9deb-494a-939d-49ce77ef2c1b (view SPL)TobraDex (tobramycin and dexamethasone ophthalmic ointment) SterileprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-261545692590
25538d748-215c-4e3e-b940-ac9baf07d8a1 (view SPL)TobraDex (tobramycin and dexamethasone ophthalmic ointment) SterileprescriptionHuman PrescriptionAlcon Laboratories, Inc.manufacture2011-07-183000650648
3fe08bcd5-4d14-4c2d-940c-b7968f9a89f0 (view SPL)TobraDexprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-271216950628

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