FDA.reportPublic FDA data

Application 212939

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEINJECTABLE;INJECTION15MG/MLNoNo
002KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEINJECTABLE;INJECTION30MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-339KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEAuroMedics Pharma LLCANDACurrent
55150-339KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEAuroMedics Pharma LLCANDACurrent
55150-340KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEAuroMedics Pharma LLCANDACurrent
55150-340KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEAuroMedics Pharma LLCANDACurrent
55150-341KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEAuroMedics Pharma LLCANDACurrent
55150-341KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEAuroMedics Pharma LLCANDACurrent