FDA.reportPublic FDA data

Application 202514

Type
NDA
Sponsor
OAK PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIOPTANTAFLUPROSTSOLUTION/DROPS;OPHTHALMIC0.0015%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-609ZIOPTANtafluprostAkorn, Inc.NDACurrent
17478-609ZIOPTANtafluprostAkorn, Inc.NDACurrent
17478-609ZIOPTANtafluprostAkornNDACurrent
17478-609ZIOPTANtafluprostAkorn, Inc.NDACurrent
17478-609ZIOPTANtafluprostAkornNDACurrent
17478-609ZIOPTANtafluprostAkorn, Inc.NDACurrent
66993-429Tafluprost OphthalmictafluprostPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
82584-609ZIOPTANTafluprostThea Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85185SUPPL 2026-03-02
85173SUPPL 2026-02-27
10064SUPPL2015-09-22
10063SUPPL2015-09-22
40191SUPPL2015-09-08
19356SUPPL2015-09-08
19355SUPPL2013-02-26
10062SUPPL2013-02-26
22890ORIG2012-03-13
10061ORIG2012-02-14
40190ORIG2012-02-13