FDA.reportPublic FDA data

Application 021398

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COMBIGANBRIMONIDINE TARTRATE; TIMOLOL MALEATESOLUTION/DROPS;OPHTHALMIC0.2%;EQ 0.5% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
0023-9211COMBIGANbrimonidine tartrate, timolol maleateAllergan, Inc.NDACurrent
60505-6225Brimonidine Tartrate/Timolol Maleatebrimonidine tartrate, timolol maleateApotex CorpNDA AUTHORIZED GENERICCurrent
60505-6225Brimonidine Tartrate/Timolol Maleatebrimonidine tartrate, timolol maleateApotex CorpNDACurrent
82182-455BRIMONIDINE TARTRATE and TIMOLOL MALEATEBRIMONIDINE TARTRATE, TIMOLOL MALEATEPacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85471SUPPL 2026-03-24
85394SUPPL 2026-03-19
36817SUPPL2015-10-22
27666SUPPL2015-10-16
5249SUPPL2012-10-15
15361SUPPL2012-10-12
24196ORIG2008-07-22
42137ORIG2008-04-22
27665ORIG2007-11-08
53203ORIG1900-01-01
53202ORIG1900-01-01
53201ORIG1900-01-01