FDA.reportPublic FDA data

Application 215733

Type
ANDA
Sponsor
DR REDDYS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-747Timolol Maleate Ophthalmic Gel Forming Solution 0.25%Timolol Maleate Ophthalmic Gel Forming Solution 0.25%Dr. Reddy's Laboratories, Inc.ANDACurrent
43598-747Timolol Maleate Ophthalmic Gel Forming Solution 0.25%Timolol Maleate Ophthalmic Gel Forming Solution 0.25%Dr. Reddy's Laboratories, Inc.ANDACurrent
43598-747Timolol Maleate Ophthalmic Gel Forming Solution 0.25%Timolol Maleate Ophthalmic Gel Forming Solution 0.25%Dr. Reddy's Laboratories, Inc.ANDACurrent
43598-748Timolol Maleate Ophthalmic Gel Forming Solution 0.5%Timolol Maleate Ophthalmic Gel Forming Solution 0.5%Dr. Reddy's Laboratories, Inc.ANDACurrent
43598-748Timolol Maleate Ophthalmic Gel Forming Solution 0.5%Timolol Maleate Ophthalmic Gel Forming Solution 0.5%Dr. Reddy's Laboratories, Inc.ANDACurrent
43598-748Timolol Maleate Ophthalmic Gel Forming Solution 0.5%Timolol Maleate Ophthalmic Gel Forming Solution 0.5%Dr. Reddy's Laboratories, Inc.ANDACurrent