Application 019700

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACULARKETOROLAC TROMETHAMINESOLUTION/DROPS;OPHTHALMIC0.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-2181AcularKetorolac TromethamineAllergan, Inc.NDACurrent
0023-2181AcularKetorolac TromethamineAllergan, Inc.NDACurrent
0023-2181AcularKetorolac TromethamineAllergan, Inc.NDACurrent
21695-463ACULARKETOROLAC TROMETHAMINERebel Distributors Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83402SUPPL 2025-09-19
83389SUPPL 2025-09-19
11641SUPPL2012-06-18
1517SUPPL2012-06-18
20299SUPPL2009-01-12
33877SUPPL2005-03-11
19108SUPPL2005-03-11
11640SUPPL2005-03-11
1516SUPPL2005-03-11
11639SUPPL2003-06-16
33876SUPPL2002-02-08
19107SUPPL2002-02-08