FDA.reportPublic FDA data

Application 204216

Type
ANDA
Sponsor
GLAND 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
0404-9883KETOROLAC TROMETHAMINEketorolac tromethamineHenry Schein, Inc.ANDACurrent
0404-9883KETOROLAC TROMETHAMINEketorolac tromethamineHenry Schein, Inc.ANDACurrent
0404-9883KETOROLAC TROMETHAMINEketorolac tromethamineHenry Schein, Inc.ANDACurrent
0404-9884Ketorolac TromethamineKetorolac TromethamineHenry Schein, Inc.ANDACurrent
0404-9884Ketorolac TromethamineKetorolac TromethamineHenry Schein, Inc.ANDACurrent
0404-9952KETOROLAC TROMETHAMINEketorolac tromethamineHenry Schein, Inc.ANDACurrent
0404-9952KETOROLAC TROMETHAMINEketorolac tromethamineHenry Schein, Inc.ANDACurrent
47781-583Ketorolac Tromethamineketorolac tromethamineAlvogen Inc.ANDACurrent
47781-583Ketorolac Tromethamineketorolac tromethamineAlvogen Inc.ANDACurrent
47781-583Ketorolac Tromethamineketorolac tromethamineAlvogen Inc.ANDACurrent
47781-584Ketorolac Tromethamineketorolac tromethamineAlvogen Inc.ANDACurrent
47781-584Ketorolac Tromethamineketorolac tromethamineAlvogen Inc.ANDACurrent
47781-584Ketorolac Tromethamineketorolac tromethamineAlvogen Inc.ANDACurrent
47781-585Ketorolac Tromethamineketorolac tromethamineAlvogen Inc.ANDACurrent
47781-585Ketorolac Tromethamineketorolac tromethamineAlvogen Inc.ANDACurrent
47781-585Ketorolac Tromethamineketorolac tromethamineAlvogen Inc.ANDACurrent
50090-3261Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-3364Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-3364Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-3397Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-4635Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-5013Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-5013Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-5013Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50090-5428Ketorolac tromethamineKetorolac tromethamineA-S Medication SolutionsANDACurrent
50090-5428Ketorolac tromethamineKetorolac tromethamineA-S Medication SolutionsANDACurrent
50090-5428Ketorolac tromethamineKetorolac tromethamineA-S Medication SolutionsANDACurrent
50090-5609Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
51662-1488KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1488KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-584Ketorolac TromethamineKetorolac TromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-584Ketorolac TromethamineKetorolac TromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-585Ketorolac TromethamineKetorolac TromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-585Ketorolac TromethamineKetorolac TromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-585Ketorolac TromethamineKetorolac TromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-719KETOROLAC TROMETHAMINEketorolac tromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-719KETOROLAC TROMETHAMINEketorolac tromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-722KETOROLAC TROMETHAMINEketorolac tromethamineGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-722KETOROLAC TROMETHAMINEketorolac tromethamineGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-722KETOROLAC TROMETHAMINEketorolac tromethamineGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-722KETOROLAC TROMETHAMINEketorolac tromethamineGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-725Ketorolac TromethamineKetorolac TromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-725Ketorolac TromethamineKetorolac TromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-725Ketorolac TromethamineKetorolac TromethamineGeneral Injectables and Vaccines, Inc.ANDACurrent
55154-1555Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-1555Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-1555Ketorolac Tromethamineketorolac tromethamineCardinal Health 107, LLCANDACurrent
55154-1555Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-1556Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-1556Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-1556Ketorolac Tromethamineketorolac tromethamineCardinal Health 107, LLCANDACurrent
55154-1556Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-1556Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-8425Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-8425Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-8426Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
55154-8426Ketorolac Tromethamineketorolac tromethamineCardinal HealthANDACurrent
68071-4811Ketorolac Tromethamineketorolac tromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4811Ketorolac Tromethamineketorolac tromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
68083-132ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-132ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-132ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-132ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-132ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-133ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-133ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-133ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-133ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-133ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-134ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-134ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-134ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-134ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
68083-134ketorolac tromethamineketorolac tromethamineGland Pharma LimitedANDACurrent
70518-1159Ketorolac Tromethamineketorolac tromethamineREMEDYREPACK INC.ANDACurrent
70518-1669Ketorolac Tromethamineketorolac tromethamineREMEDYREPACK INC.ANDACurrent
70518-1889Ketorolac Tromethamineketorolac tromethamineREMEDYREPACK INC.ANDACurrent
70518-1889Ketorolac Tromethamineketorolac tromethamineREMEDYREPACK INC.ANDACurrent
70518-2608Ketorolac Tromethamineketorolac tromethamineREMEDYREPACK INC.ANDACurrent
70518-2610Ketorolac Tromethamineketorolac tromethamineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45796ORIG2016-11-03