FDA.reportPublic FDA data

Application 050810

Type
NDA
Sponsor
OAK PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZASITEAZITHROMYCINSOLUTION/DROPS;OPHTHALMIC1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-307AzaSITEAzithromycin MonohydrateAkornNDACurrent
17478-307AzaSITEAzithromycin MonohydrateAkorn, Inc.NDACurrent
17478-307AzaSITEAzithromycin MonohydrateAkorn, Inc.NDACurrent
17478-307AzaSITEAzithromycin MonohydrateAkorn, Inc.NDACurrent
82584-307AZASITEazithromycin monohydrateThea Pharma Inc.NDACurrent
82584-307AZASITEazithromycin monohydrateThea Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79243SUPPL 2024-07-29
79218SUPPL 2024-07-26
70152SUPPL2022-02-14
69345SUPPL2021-11-18
22249SUPPL2013-02-27
18293SUPPL2012-10-17
39379SUPPL2012-07-10
8332SUPPL2012-07-09
30602SUPPL2011-04-04
39378SUPPL2011-04-01
22248ORIG2009-08-13
30601SUPPL2009-05-11
8331SUPPL2009-05-11
8330SUPPL2009-05-11
39377ORIG2007-05-01
30600ORIG2007-05-01