FDA.reportPublic FDA data

Application 077846

Type
ANDA
Sponsor
HI TECH PHARMA

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
50090-1246Dorzolamide HydrochlorideDorzolamide HydrochlorideA-S Medication SolutionsANDACurrent
50090-1246Dorzolamide HydrochlorideDorzolamide HydrochlorideA-S Medication SolutionsANDACurrent
50090-1246Dorzolamide HydrochlorideDorzolamide HydrochlorideA-S Medication SolutionsANDACurrent
50090-1246Dorzolamide HydrochlorideDorzolamide HydrochlorideA-S Medication SolutionsANDACurrent
50383-232Dorzolamide HydrochlorideDorzolamide HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-232Dorzolamide HydrochlorideDorzolamide HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-232Dorzolamide HydrochlorideDorzolamide HydrochlorideAkornANDACurrent
50383-232Dorzolamide HydrochlorideDorzolamide HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-232Dorzolamide HydrochlorideDorzolamide HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
60429-114Dorzolamide HydrochlorideDorzolamide HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-114Dorzolamide HydrochlorideDorzolamide HydrochlorideGolden State Medical SupplyANDACurrent
60429-114Dorzolamide HydrochlorideDorzolamide HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-114Dorzolamide HydrochlorideDorzolamide HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-114Dorzolamide HydrochlorideDorzolamide HydrochlorideGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31292ORIG2008-10-29