FDA.report

Application 074754

Type
ANDA
Sponsor
TEVA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINETABLET;ORAL10MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0314Ketorolac TromethamineKetorolac TromethamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0314Ketorolac TromethamineKetorolac TromethamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0314Ketorolac TromethamineKetorolac TromethamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0314Ketorolac TromethamineKetorolac TromethamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0314Ketorolac TromethamineKetorolac TromethamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0314Ketorolac TromethamineKetorolac TromethamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0314Ketorolac TromethamineKetorolac TromethamineTeva Pharmaceuticals USA, Inc.ANDACurrent
10544-222Ketorolac TromethamineKetorolac TromethamineBlenheim Pharmacal, Inc.ANDACurrent
12634-809Ketorolac TromethamineKetorolac TromethamineApotheca, IncANDACurrent
21695-432Ketorolac TromethamineKetorolac TromethamineRebel Distributors CorpANDACurrent
33261-065Ketorolac TromethamineKetorolac TromethamineAidarex Pharmaceuticals LLCANDACurrent
35356-696Ketorolac TromethamineKetorolac TromethamineLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-696Ketorolac TromethamineKetorolac TromethamineLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-696Ketorolac TromethamineKetorolac TromethamineLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-696Ketorolac TromethamineKetorolac TromethamineLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-696Ketorolac TromethamineKetorolac TromethamineLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-696Ketorolac TromethamineKetorolac TromethamineLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-696Ketorolac TromethamineKetorolac TromethamineLake Erie Medical DBA Quality Care Products LLCANDACurrent
42291-358Ketorolac TromethamineKetorolac TromethamineAvKARE, Inc.ANDACurrent
42291-358Ketorolac TromethamineKetorolac TromethamineAvKARE, Inc.ANDACurrent
42291-358Ketorolac TromethamineKetorolac TromethamineAvKAREANDACurrent
43063-904Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-904Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-904Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-904Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-904Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-904Ketorolac TromethamineKetorolac TromethaminePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-657Ketorolac TromethamineKetorolac TromethamineMedsource PharmaceuticalsANDACurrent
50090-0601Ketorolac TromethamineKetorolac TromethamineA-S Medication SolutionsANDACurrent
50090-0601Ketorolac TromethamineKetorolac TromethamineA-S Medication SolutionsANDACurrent
50436-7382Ketorolac TromethamineKetorolac TromethamineUnit Dose ServicesANDACurrent
51655-170Ketorolac TromethamineKetorolac TromethamineNorthwind Pharmaceuticals, LLCANDACurrent
51655-170Ketorolac TromethamineKetorolac TromethamineNorthwind PharmaceuticalsANDACurrent
52959-512Ketorolac TromethamineKetorolac TromethamineH.J. Harkins Company, Inc.ANDACurrent
53002-6990Ketorolac TromethamineKetorolac TromethamineRPK Pharmaceuticals, Inc.ANDACurrent
53002-6990Ketorolac TromethamineKetorolac TromethamineRPK Pharmaceuticals, Inc.ANDACurrent
60687-104Ketorolac TromethamineKetorolac TromethamineAmerican Health PackagingANDACurrent
60687-104Ketorolac TromethamineKetorolac TromethamineAmerican Health PackagingANDACurrent
60760-314Ketorolac TromethamineKetorolac TromethamineSt. MaryANDACurrent
61919-138KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEDIRECT RXANDACurrent
61919-138KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEDIRECT RXANDACurrent
61919-138KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEDIRECT RXANDACurrent
63187-128Ketorolac TromethamineKetorolac TromethamineProficient Rx LPANDACurrent
63187-128Ketorolac TromethamineKetorolac TromethamineProficient Rx LPANDACurrent
63187-128Ketorolac TromethamineKetorolac TromethamineProficient Rx LPANDACurrent
63187-128Ketorolac TromethamineKetorolac TromethamineProficient Rx LPANDACurrent
63187-128Ketorolac TromethamineKetorolac TromethamineProficient Rx LPANDACurrent
63187-128Ketorolac TromethamineKetorolac TromethamineProficient Rx LPANDACurrent
63629-2974Ketorolac TromethamineKetorolac TromethamineBryant Ranch PrepackANDACurrent
63629-2974Ketorolac TromethamineKetorolac TromethamineBryant Ranch PrepackANDACurrent
63629-2974Ketorolac TromethamineKetorolac TromethamineBryant Ranch PrepackANDACurrent
66267-418Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
66267-418Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-418Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-418Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
66267-418Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
66267-418Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
66267-418Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
66267-418Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-832Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals, IANDACurrent
66267-832Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-832Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-832Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals, Inc.ANDACurrent
67296-0511Ketorolac TromethamineKetorolac TromethamineRedPharm Drug, Inc.ANDACurrent
68071-2737Ketorolac TromethamineKetorolac TromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
68151-0098Ketorolac TromethamineKetorolac TromethamineCarilion Materials ManagementANDACurrent
68387-440Ketorolac TromethamineKetorolac TromethamineKeltman Pharmaceuticals Inc.ANDACurrent
68788-8149Ketorolac TromethamineKetorolac TromethaminePreferred Pharmaceuticals Inc.ANDACurrent
68788-9205Ketorolac TromethamineKetorolac TromethaminePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0048Ketorolac TromethamineKetorolac TromethamineREMEDYREPACK INC.ANDACurrent
70518-0048Ketorolac TromethamineKetorolac TromethamineREMEDYREPACK INC.ANDACurrent
70518-0048Ketorolac TromethamineKetorolac TromethamineREMEDYREPACK INC.ANDACurrent
70518-0048Ketorolac TromethamineKetorolac TromethamineREMEDYREPACK INC.ANDACurrent
70518-0048Ketorolac TromethamineKetorolac TromethamineREMEDYREPACK INC.ANDACurrent
70518-0048Ketorolac TromethamineKetorolac TromethamineREMEDYREPACK INC.ANDACurrent
70518-0048Ketorolac TromethamineKetorolac TromethamineREMEDYREPACK INC.ANDACurrent
70518-0048Ketorolac TromethamineKetorolac TromethamineREMEDYREPACK INC.ANDACurrent
70934-029Ketorolac TromethamineKetorolac TromethamineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-029Ketorolac TromethamineKetorolac TromethamineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-029Ketorolac TromethamineKetorolac TromethamineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
428760ORIG11997-05-16