FDA.reportPublic FDA data

Application 202667

Type
NDA
Sponsor
OAK PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COSOPT PFDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATESOLUTION/DROPS;OPHTHALMICEQ 2% BASE;EQ 0.5% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-604COSOPT PFDorzolamide Hydrochloride and Timolol MaleateAkorn, Inc.NDACurrent
17478-604COSOPT PFDorzolamide Hydrochloride and Timolol MaleateAkorn, Inc.NDACurrent
17478-604COSOPT PFDorzolamide Hydrochloride and Timolol MaleateAkorn, Inc.NDACurrent
17478-604COSOPT PFDorzolamide Hydrochloride and Timolol MaleateAkornNDACurrent
50383-261Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateHi-Tech Pharmacal Co., Inc.NDACurrent
50383-261Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateAkornNDACurrent
50383-261Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateHi-Tech Pharmacal Co., Inc.NDACurrent
50383-261Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateHi-Tech Pharmacal Co., Inc.NDACurrent
82584-604COSOPT PFdorzolamide hydrochloride and timolol maleateThea Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85679SUPPL 2026-04-14
85676SUPPL 2026-04-14
85674SUPPL 2026-04-10
24420ORIG2012-11-13
22894ORIG2012-11-13
19366ORIG2012-02-06
10092ORIG2012-02-03