FDA.reportPublic FDA data

Application 020408

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRUSOPTDORZOLAMIDE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 2% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3519TRUSOPTdorzolamide hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-3519TRUSOPTdorzolamide hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-3519TRUSOPTdorzolamide hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-3519TRUSOPTdorzolamide hydrochlorideMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65764SUPPL2020-12-28
65699SUPPL2020-12-23
24935SUPPL2014-02-10
12554SUPPL2014-02-06
12553SUPPL2010-06-24
2500SUPPL2010-06-22
34624SUPPL2008-11-07
24934SUPPL2008-10-24
20650SUPPL2008-07-31
24933SUPPL2006-01-19
34623SUPPL2006-01-05
12552SUPPL2004-05-03
24932SUPPL2004-04-20
12551SUPPL2002-04-12
2498SUPPL2002-04-12
34622SUPPL2002-04-09
2499SUPPL2002-04-09
51841SUPPL1900-01-01
51840SUPPL1900-01-01
51838SUPPL1900-01-01
51836SUPPL1900-01-01
51834SUPPL1900-01-01