Ketorolac Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-07-13)
Oldest Current Product
1998-06-17
License(s)
ANDA
RxNORM
ORAL TABLET\KETOROLAC
FDAOB
ORAL\TABLET\KETOROLAC TROMETHAMINE
SPL Active
ORAL\TABLET, FILM COATED\KETOROLAC TROMETHAMINE
ORAL\TABLET\KETOROLAC TROMETHAMINE
SPL Moiety
ORAL\TABLET, FILM COATED\KETOROLAC
ORAL\TABLET, FILM COATED\KETOROLAC TROMETHAMINE
ORAL\TABLET\KETOROLAC

product(s) by strength(s)

ketorolac tromethamine 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930314ANDATeva Pharmaceuticals Usa Inc1998-06-17KETOROLAC TROMETHAMINEORALTABLET, FILM COATEDANDA074754688f5dec-a6db-43c6-a1f8-5df99d08d395
2003781134ANDAMylan Pharmaceuticals Inc.2013-05-16KETOROLAC TROMETHAMINEORALTABLET, FILM COATEDANDA0747612837a082-3a34-6f81-5e43-45a70295686b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440222ANDABlenheim Pharmacal, Inc.2011-07-15KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA0747541191f151-ab29-1f7e-e054-00144ff88e88
2126340809ANDAApotheca, Inc2005-10-25KETOROLAC TROMETHAMINEORALTABLET000930314ANDA074754e20df5b6-84da-4715-b36e-bb7e4be55416
3165900138ANDAStat Rx Usa Llc2010-09-15KETOROLAC TROMETHAMINEORALTABLET, FILM COATED003781134ANDA074761dce94664-7e3d-4592-86ac-2a94231e484b
4216950432ANDARebel Distributors Corp2010-04-20KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA0747545914ef00-19b1-4e22-9ad3-2b62b455af9d
5332610065ANDAAidarex Pharmaceuticals Llc1998-06-17KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA07475411b38f8d-26e0-4614-97ba-722505b0ffb0
6353560696ANDALake Erie Medical Dba Quality Care Products Llc2010-04-20KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA07475486142f73-00fc-48d6-8383-3c28bd0b5832
7425490538ANDAStat Rx Usa Llc2010-09-15KETOROLAC TROMETHAMINEORALTABLET, FILM COATED003781134ANDA074761a41b9710-a1ec-41be-8417-b03c5d802ae2
8430630174ANDAPd-Rx Pharmaceuticals, Inc.2010-09-15KETOROLAC TROMETHAMINEORALTABLET, FILM COATED003781134ANDA074761e8593016-2bec-4c62-a10f-e7e944c26755
9493490114ANDARemedyrepack Inc.2010-12-06KETOROLAC TROMETHAMINEORALTABLET003781134ANDA074761026da3c7-c865-4eff-a6e5-381f9645f717
10493490737ANDARemedyrepack Inc.2011-12-28, 2012-09-04, 2013-12-11KETOROLAC TROMETHAMINEORALTABLET000930314ANDA074754763213c9-3e4b-4ea1-a544-f7d3720568ad, 7f20b5e8-c40b-486f-b846-4abc79d25f51, a833b151-55cc-429b-94e7-743da0060563, ea26594b-7606-4073-abeb-ef2aba18b05c
11499990130ANDALake Erie Medical Dba Quality Care Products Llc2010-11-17KETOROLAC TROMETHAMINEORALTABLET, FILM COATED003781134ANDA074761a28547a9-0831-488b-bfdf-7ae8bed82da9
12504367382ANDAUnit Dose Services2010-04-20KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA07475436087b99-a193-4dee-a103-8739484f4591
13516550170ANDANorthwind Pharmaceuticals, Llc2014-07-15KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA074754d17ed469-677b-4a2e-96a9-5cfd0f50ecd9
14529590512ANDAH.J. Harkins Company, Inc.2010-04-20KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA074754b701aef5-3f70-4bc2-abe7-7047b6a6e2a5
15548684171ANDAPhysicians Total Care, Inc.2001-01-10KETOROLAC TROMETHAMINEORALTABLET, FILM COATED003781134ANDA074761e61ae711-e6d2-44e4-b7d7-943a9d06f985
16551548264ANDACardinal Health2010-04-20KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA0747543d5a25e6-a117-47fd-b23e-d67597552c0f
17552890328ANDAPd-Rx Pharmaceuticals, Inc.2010-09-15KETOROLAC TROMETHAMINEORALTABLET, FILM COATED003781134ANDA074761463cb005-7ba6-4f8c-835d-ba8f1714a6e1
18581180314ANDAClinical Solutions Wholesale1998-06-17KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA074754e463ff2c-e88d-47b8-b985-1ff55c7f3a6a
19619190138ANDADirect Rx2014-01-01KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA074754a42517a0-245e-44ec-b9fc-cf4e4b4a8989
20631870128ANDAProficient Rx Lp1998-06-17KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA074754f5170993-81a9-4eb7-95ac-60697a5ee1d7
21636292974ANDABryant Ranch Prepack2010-04-20KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA074754f713500a-20b8-8e20-c4cc-956805170335
22642050113ANDAReadymeds2013-05-16KETOROLAC TROMETHAMINEORALTABLET, FILM COATED003781134ANDA0747612f4057b1-4707-4975-949e-3d62133d96f9
23681510098ANDACarilion Materials Management1998-06-17KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA07475419300bc5-39ba-47b7-bfda-036b0a2649ae
24683870440ANDAKeltman Pharmaceuticals Inc.2010-04-20KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA0747549a6df709-e016-44e1-8e1d-dea46689c3c8
25687889205ANDAPreferred Pharmaceuticals, Inc.2015-01-21KETOROLAC TROMETHAMINEORALTABLET, FILM COATED000930314ANDA074754153d3376-4e38-4f5e-8bf7-4b77bcbb2ebe

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074754KETOROLAC TROMETHAMINETEVA PHARMACEUTICALS USA INC1997-05-16ANDA074754_001
2ANDA074761KETOROLAC TROMETHAMINEMYLAN PHARMACEUTICALS INC1997-05-16ANDA074761_001
3ANDA074790KETOROLAC TROMETHAMINETrueCYCLE PHARMACEUTICALS LTD1997-06-26ANDA074790_001
4ANDA074955KETOROLAC TROMETHAMINETrueWATSON LABORATORIES INC1997-09-19ANDA074955_001
5ANDA075284KETOROLAC TROMETHAMINEPLIVA INC1999-06-23ANDA075284_001
6NDA019645TORADOLTrueROCHE PALO ALTO LLC1991-12-20NDA019645_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074754_001RXKETOROLAC TROMETHAMINE (10MG)ORALTABLETFalseAB1997-05-16KETOROLAC TROMETHAMINE
2ANDA074761_001RXKETOROLAC TROMETHAMINE (10MG)ORALTABLETTrueAB1997-05-16KETOROLAC TROMETHAMINE
3ANDA074790_001discontinuedKETOROLAC TROMETHAMINE (10MG)ORALTABLETFalse1997-06-26KETOROLAC TROMETHAMINE
4ANDA074955_001discontinuedKETOROLAC TROMETHAMINE (10MG)ORALTABLETFalse1997-09-19KETOROLAC TROMETHAMINE
5ANDA075284_001RXKETOROLAC TROMETHAMINE (10MG)ORALTABLETFalseAB1999-06-23KETOROLAC TROMETHAMINE
6NDA019645_001discontinuedKETOROLAC TROMETHAMINE (10MG)ORALTABLETFalse1991-12-20TORADOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1026da3c7-c865-4eff-a6e5-381f9645f717 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-12-06121493490114
21191f151-ab29-1f7e-e054-00144ff88e88 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx onlyprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-06-052105440222
311b38f8d-26e0-4614-97ba-722505b0ffb0 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg0314Rx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-051332610065
4153d3376-4e38-4f5e-8bf7-4b77bcbb2ebe (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-212687889205
519300bc5-39ba-47b7-bfda-036b0a2649ae (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-04-143681510098
62837a082-3a34-6f81-5e43-45a70295686b (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-135003781134
72f4057b1-4707-4975-949e-3d62133d96f9 (view SPL)prescriptionHuman PrescriptionReadymedsrepack2014-05-155642050113
836087b99-a193-4dee-a103-8739484f4591 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2010-04-202504367382
93d5a25e6-a117-47fd-b23e-d67597552c0f (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2014-09-095551548264
10463cb005-7ba6-4f8c-835d-ba8f1714a6e1 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2008-08-224552890328
115914ef00-19b1-4e22-9ad3-2b62b455af9d (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg0314Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-291216950432
12688f5dec-a6db-43c6-a1f8-5df99d08d395 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-129000930314
13763213c9-3e4b-4ea1-a544-f7d3720568ad (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-12-283493490737
147f20b5e8-c40b-486f-b846-4abc79d25f51 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-09-041493490737
1586142f73-00fc-48d6-8383-3c28bd0b5832 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg0314Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-07-033904353560696
169a6df709-e016-44e1-8e1d-dea46689c3c8 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mgRx onlyprescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.repack2010-09-212683870440
17a28547a9-0831-488b-bfdf-7ae8bed82da9 (view SPL)Ketorolac Tromethamine 10 MGprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, repack2010-11-17466499990130
18a41b9710-a1ec-41be-8417-b03c5d802ae2 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-04-111425490538
19a42517a0-245e-44ec-b9fc-cf4e4b4a8989 (view SPL)KETOROLAC TROMETHAMINEprescriptionHuman PrescriptionDirect Rxrepack2015-06-252619190138
20a833b151-55cc-429b-94e7-743da0060563 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg0314Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-114493490737
21b701aef5-3f70-4bc2-abe7-7047b6a6e2a5 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg0314Rx onlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-10-211529590512
22d17ed469-677b-4a2e-96a9-5cfd0f50ecd9 (view SPL)Ketorolac TromethamineprescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-07-211516550170
23dce94664-7e3d-4592-86ac-2a94231e484b (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-08-161165900138
24e20df5b6-84da-4715-b36e-bb7e4be55416 (view SPL)Ketorolac Tromethamine Tablets, USP 10mgprescriptionHuman PrescriptionApotheca, Increpack2014-01-172126340809
25e463ff2c-e88d-47b8-b985-1ff55c7f3a6a (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx onlyprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-08-085581180314
26e61ae711-e6d2-44e4-b7d7-943a9d06f985 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-03-171548684171
27e8593016-2bec-4c62-a10f-e7e944c26755 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2008-08-223430630174
28ea26594b-7606-4073-abeb-ef2aba18b05c (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg0314Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-113493490737
29f5170993-81a9-4eb7-95ac-60697a5ee1d7 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-06-061631870128
30f713500a-20b8-8e20-c4cc-956805170335 (view SPL)KETOROLAC TROMETHAMINE TABLETS USP, 10 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636292974

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII