FDA.reportPublic FDA data

Application 091691

Type
ANDA
Sponsor
INDOCO REMEDIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATESOLUTION/DROPS;OPHTHALMIC0.2%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
14445-400Brimonidine TartrateBrimonidine TartrateIndoco Remedies LimitedANDACurrent
42843-501Brimonidine TartrateBrimonidine TartrateOsmotica Pharmaceutical Corp.ANDACurrent
71921-185Brimonidine TartrateBrimonidine TartrateFlorida Pharmaceutical Products, LLCANDACurrent
71921-185Brimonidine TartrateBrimonidine TartrateFlorida Pharmaceutical Products, LLCANDACurrent