FDA.reportPublic FDA data

Application 205191

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINESOLUTION/DROPS;OPHTHALMIC0.4%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65862-775Ketorolac TromethamineKetorolac TromethamineAurobindo Pharma LimitedANDACurrent
65862-775Ketorolac TromethamineKetorolac TromethamineAurobindo Pharma LimitedANDACurrent
65862-775Ketorolac TromethamineKetorolac TromethamineAurobindo Pharma LimitedANDACurrent
65862-775Ketorolac TromethamineKetorolac TromethamineAurobindo Pharma LimitedANDACurrent