FDA.reportPublic FDA data

Application 205388

Type
NDA
Sponsor
OMEROS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMIDRIAKETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDESOLUTION;IRRIGATIONEQ 0.3% BASE;EQ 1% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62225-600Omidriaphenylephrine and ketorolacOmeros CorporationNDACurrent
62225-600Omidriaphenylephrine and ketorolacOmeros CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50778SUPPL2017-12-20
50654SUPPL2017-12-11
19641SUPPL2016-06-24
24493ORIG2014-12-09
22986ORIG2014-12-09
32666ORIG2014-06-03
19640ORIG2014-06-03
51555SUPPL1900-01-01
51554SUPPL1900-01-01
51553SUPPL1900-01-01