FDA.reportPublic FDA data

Application 022382

Type
NDA
Sponsor
ZYLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPRIXKETOROLAC TROMETHAMINESPRAY, METERED;NASAL15.75MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66993-193Ketorolac Tromethamineketorolac tromethaminePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-193Ketorolac Tromethamineketorolac tromethaminePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-193Ketorolac Tromethamineketorolac tromethaminePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
69344-144Sprixketorolac tromethamineZyla Life Sciences US Inc.NDACurrent
69344-144Sprixketorolac tromethamineEgalet US Inc.NDACurrent
69344-144Sprixketorolac tromethamineEgalet US Inc.NDACurrent
69344-144Sprixketorolac tromethamineZyla Life Sciences US Inc.NDACurrent
69344-144Sprixketorolac tromethamineZyla Life Sciences US Inc.NDACurrent
76519-1017Sprixketorolac tromethamineH.J. Harkins Company, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80392SUPPL 2024-11-25
80391SUPPL 2024-11-25
80310SUPPL 2024-11-22
67372SUPPL2021-05-03
67371SUPPL2021-05-03
67275SUPPL2021-04-30
51900SUPPL2018-01-26
51563SUPPL2018-01-24
51405SUPPL2018-01-22
38639SUPPL2016-05-11
38638SUPPL2016-05-11
29665SUPPL2016-05-10
7306SUPPL2016-05-10
38637SUPPL2014-04-22
29664SUPPL2014-04-22
42502ORIG2011-05-03
24293ORIG2011-05-03
38636ORIG2010-05-28
29663ORIG2010-05-21