FDA.reportPublic FDA data

Application 020963

Type
NDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIMOLOL MALEATETIMOLOL MALEATESOLUTION, GEL FORMING/DROPS;OPHTHALMICEQ 0.25% BASEYesYes
002TIMOLOL MALEATETIMOLOL MALEATESOLUTION, GEL FORMING/DROPS;OPHTHALMICEQ 0.5% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61314-224Timolol GFStimolol maleateSandoz IncNDACurrent
61314-224Timolol GFStimolol maleateSandoz IncNDACurrent
61314-224Timolol GFStimolol maleateSandoz IncNDACurrent
61314-225Timolol GFStimolol maleateSandoz IncNDACurrent
61314-225Timolol GFStimolol maleateSandoz IncNDACurrent
61314-225Timolol GFStimolol maleateSandoz IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78584SUPPL 2024-05-30
78569SUPPL 2024-05-29
3852SUPPL2007-06-14
13819SUPPL2007-06-12
26302SUPPL2003-07-08
13818SUPPL2003-07-08
41843ORIG2003-05-22
13817SUPPL2003-04-25
35721ORIG1998-10-21
3851ORIG1998-10-21
53132ORIG1900-01-01
53131ORIG1900-01-01