FDA.report

Application 074802

Type
ANDA
Sponsor
HOSPIRA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEINJECTABLE;INJECTION15MG/MLNoYes
002KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEINJECTABLE;INJECTION30MG/MLNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3793Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3795Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
0409-3796Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.ANDACurrent
50090-1328Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication SolutionsANDACurrent
50090-1521Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication SolutionsANDACurrent
51662-1292KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1292KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1292KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1292KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1292KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1292KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1292KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1295KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1295KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1295KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1295KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1295KETOROLAC TROMETHAMKETOROLAC TROMETHAMHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1295KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1295KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-795Ketorolac TromethamineKetorolac TromethamineGeneral Injectables & Vaccines, IncANDACurrent
53225-3655ReadySharp KetorolacKETOROLAC TROMETHAMINETerrain PharmaceuticalsANDACurrent
53225-3655ReadySharp KetorolacKETOROLAC TROMETHAMINETerrain PharmaceuticalsANDACurrent
55154-0120Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-0120Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-0120Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-0120Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-0120Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-0149Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-6960Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-6960Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-6960Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-6960Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
55154-6960Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal HealthANDACurrent
68071-1785Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals,Inc.ANDACurrent
68071-1787Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals,Inc.ANDACurrent
68071-1787Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals,Inc.ANDACurrent
68788-7439ReadySharp KetorolacKETOROLAC TROMETHAMINEPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1074Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.ANDACurrent
70518-1074Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.ANDACurrent
70518-1074Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.ANDACurrent
71872-7022Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLCANDACurrent
71872-7022Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLCANDACurrent
71872-7188Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLCANDACurrent
76420-184Ketorolac TromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.ANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
183670SUPPL382015-07-23