Application 202053

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 2% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
14445-404Dorzolamide HydrochlorideDorzolamideIndoco Remedies LimitedANDACurrent
50090-2768Dorzolamide HClDorzolamide HydrochlorideA-S Medication SolutionsANDACurrent
70377-081Dorzolamide HydrochlorideDorzolamideBiocon Pharma Inc.ANDACurrent
70377-081Dorzolamide HydrochlorideDorzolamideBiocon Pharma Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40102ORIG2014-09-23
9947ORIG2014-09-16