FDA.reportPublic FDA data

Application 020869

Type
NDA
Sponsor
OAK PHARMS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-605COSOPTDorzolamide Hydrochloride and Timolol MaleateAkornNDACurrent
17478-605COSOPTDorzolamide Hydrochloride and Timolol MaleateAkornNDACurrent
17478-605COSOPTDorzolamide Hydrochloride and Timolol MaleateAkornNDACurrent
17478-605COSOPTDorzolamide Hydrochloride and Timolol MaleateAkornNDACurrent
17478-605COSOPTDorzolamide Hydrochloride and Timolol MaleateAkornNDACurrent
17478-605COSOPTDorzolamide Hydrochloride and Timolol MaleateAkornNDACurrent
82584-605COSOPTdorzolamide hydrochloride and timolol maleateThea Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65341SUPPL2020-11-25
65329SUPPL2020-11-25
13651SUPPL2015-08-04
3623SUPPL2015-08-03
13650SUPPL2010-06-24
26090SUPPL2010-06-22
13649SUPPL2008-11-07
26089SUPPL2008-10-23
3622SUPPL2006-08-14
35544SUPPL2006-08-11
35543SUPPL2006-05-01
35542SUPPL2006-05-01
26088SUPPL2006-05-01
3621SUPPL2006-05-01
35541SUPPL2005-12-15
3620SUPPL2005-12-15
26087SUPPL2005-03-30
13648SUPPL2005-03-30
41772ORIG2003-08-08
35540SUPPL2002-04-23
26086SUPPL2002-04-23
41773SUPPL1999-01-04
35539ORIG1998-04-07
3619ORIG1998-04-07