FDA.reportPublic FDA data

Application 076583

Type
ANDA
Sponsor
SANDOZ 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
50090-2746KETOROLAC TROMETHAMINEketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-2746KETOROLAC TROMETHAMINEketorolac tromethamineA-S Medication SolutionsANDACurrent
53002-7780KETOROLAC TROMETHAMINEketorolac tromethamineRPK Pharmaceuticals, Inc.ANDACurrent
61314-126KETOROLAC TROMETHAMINEketorolac tromethamineSandoz IncANDACurrent
61314-126KETOROLAC TROMETHAMINEketorolac tromethamineSandoz IncANDACurrent
61314-126KETOROLAC TROMETHAMINEketorolac tromethamineSandoz IncANDACurrent
61314-126KETOROLAC TROMETHAMINEketorolac tromethamineSandoz IncANDACurrent
68071-2252KETOROLAC TROMETHAMINEketorolac tromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2252KETOROLAC TROMETHAMINEketorolac tromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7517KETOROLAC TROMETHAMINEketorolac tromethaminePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7517KETOROLAC TROMETHAMINEketorolac tromethaminePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7517KETOROLAC TROMETHAMINEketorolac tromethaminePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7517KETOROLAC TROMETHAMINEketorolac tromethaminePreferred Pharmaceuticals, Inc.ANDACurrent
71205-296KETOROLAC TROMETHAMINEketorolac tromethamineProficient Rx LPANDACurrent
71205-296KETOROLAC TROMETHAMINEketorolac tromethamineProficient Rx LPANDACurrent
71205-296KETOROLAC TROMETHAMINEketorolac tromethamineProficient Rx LPANDACurrent
71205-296KETOROLAC TROMETHAMINEketorolac tromethamineProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8928ORIG2009-11-10