FDA.reportPublic FDA data

Application 074761

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1134Ketorolac TromethamineKetorolac TromethamineMylan Pharmaceuticals Inc.ANDACurrent
0378-1134Ketorolac TromethamineKetorolac TromethamineMylan Pharmaceuticals Inc.ANDACurrent
0378-1134Ketorolac TromethamineKetorolac TromethamineMylan Pharmaceuticals Inc.ANDACurrent
0378-1134Ketorolac TromethamineKetorolac TromethamineMylan Pharmaceuticals Inc.ANDACurrent
0378-1134Ketorolac TromethamineKetorolac TromethamineMylan Pharmaceuticals Inc.ANDACurrent
0378-1134Ketorolac TromethamineKetorolac TromethamineMylan Pharmaceuticals Inc.ANDACurrent
0378-1134Ketorolac TromethamineKetorolac TromethamineMylan Pharmaceuticals Inc.ANDACurrent
0378-1134Ketorolac TromethamineKetorolac TromethamineMylan Pharmaceuticals Inc.ANDACurrent
43063-174Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-328Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-328Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-328Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-328Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-328Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
64205-113Ketorolac TromethamineKetorolac TromethamineReadyMedsANDACurrent
67296-1412Ketorolac TromethamineKetorolac TromethamineRedPharm Drug, Inc.ANDACurrent
67296-1412Ketorolac TromethamineKetorolac TromethamineRedPharm Drug, Inc.ANDACurrent
71335-1803Ketorolac TromethamineKetorolac TromethamineBryant Ranch PrepackANDACurrent