FDA.reportPublic FDA data

Application 203058

Type
ANDA
Sponsor
AKORN 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
17478-514Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateAkorn, Inc.ANDACurrent
17478-514Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateAkorn, Inc.ANDACurrent
17478-514Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateAkorn, Inc.ANDACurrent
17478-514Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateAkornANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32365ORIG2014-09-24
19415ORIG2014-09-23