FDA.reportPublic FDA data

Application 021528

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACULAR LSKETOROLAC TROMETHAMINESOLUTION/DROPS;OPHTHALMIC0.4%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-9277ACULAR LSKetorolac TromethamineAllergan, Inc.NDACurrent
0023-9277ACULAR LSKetorolac TromethamineAllergan, Inc.NDACurrent
0023-9277ACULAR LSKetorolac TromethamineAllergan, Inc.NDACurrent
0023-9277ACULAR LSKetorolac TromethamineAllergan, Inc.NDACurrent
0023-9277ACULAR LSKetorolac TromethamineAllergan, Inc.NDACurrent
50090-3550KETOROLAC TROMETHAMINEKetorolac TromethamineA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3550KETOROLAC TROMETHAMINEKetorolac TromethamineA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3550KETOROLAC TROMETHAMINEKetorolac TromethamineA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3550KETOROLAC TROMETHAMINEKetorolac TromethamineA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
60758-773KETOROLAC TROMETHAMINEKetorolac TromethaminePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-773KETOROLAC TROMETHAMINEKetorolac TromethaminePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-773KETOROLAC TROMETHAMINEKetorolac TromethaminePacific Pharma, Inc.NDA AUTHORIZED Current
60758-773KETOROLAC TROMETHAMINEKetorolac TromethaminePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66701SUPPL2021-03-09
66664SUPPL2021-03-09
15695SUPPL2016-06-01
5649SUPPL2008-12-04
42201ORIG2003-11-06
15694ORIG2003-06-08
5648ORIG2003-06-08