FDA.reportPublic FDA data

Application 076109

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINESOLUTION/DROPS;OPHTHALMIC0.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-613Ketorolac Tromethamineketorolac tromethamineMedsource PharmaceuticalsANDACurrent
50090-2762Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-2762Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-2762Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
60505-1003Ketorolac Tromethamineketorolac tromethamineApotex Corp.ANDACurrent
60505-1003Ketorolac Tromethamineketorolac tromethamineApotex Corp.ANDACurrent
60505-1003Ketorolac Tromethamineketorolac tromethamineApotex Corp.ANDACurrent
63187-777Ketorolac Tromethamineketorolac tromethamineProficient Rx LPANDACurrent
63187-777Ketorolac Tromethamineketorolac tromethamineProficient Rx LPANDACurrent
63187-777Ketorolac Tromethamineketorolac tromethamineProficient Rx LPANDACurrent
68788-7384Ketorolac Tromethamineketorolac tromethaminePreferred Pharmaceuticals Inc.ANDACurrent
68788-7384Ketorolac Tromethamineketorolac tromethaminePreferred Pharmaceuticals Inc.ANDACurrent
68788-7384Ketorolac Tromethamineketorolac tromethaminePreferred Pharmaceuticals Inc.ANDACurrent
72189-054KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEDIRECT RXANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8866ORIG2009-11-09