FDA.reportPublic FDA data

Application 202054

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATESOLUTION/DROPS;OPHTHALMICEQ 2% BASE;EQ 0.5% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
14445-405DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAEddorzolamide hydrochloride timolol maleateIndoco Remedies LimitedANDACurrent
50090-2867Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateA-S Medication SolutionsANDACurrent
70377-082DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEdorzolamide hydrochloride timolol maleateBiocon Pharma Inc.ANDACurrent
70377-082DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEdorzolamide hydrochloride timolol maleateBiocon Pharma Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32159ORIG2014-09-05