Ketorolac Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-08-07)
Oldest Current Product
1997-06-05
License(s)
ANDA
RxNORM
INJECTION\KETOROLAC
FDAOB
INJECTION\INJECTION\KETOROLAC TROMETHAMINE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\KETOROLAC TROMETHAMINE
INTRAMUSCULAR\INJECTION\KETOROLAC TROMETHAMINE
INTRAVENOUS\INJECTION, SOLUTION\KETOROLAC TROMETHAMINE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\KETOROLAC
INTRAMUSCULAR\INJECTION\KETOROLAC
INTRAVENOUS\INJECTION, SOLUTION\KETOROLAC

product(s) by strength(s)

1 ml ketorolac tromethamine 15 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690085ANDAPfizer Labs2011-05-11KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTIONANDA0782996d0bc721-390c-4475-9915-d3bcccc60b76
2004093793ANDAHospira, Inc.1997-06-05KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA0748026a77b694-e9a7-417d-b9cc-e700771b6728, 8accbb78-fc64-45d5-69b0-35c23a1d2a2e
3250210700ANDASagent Pharmaceuticals2014-09-05KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA09106562591551-a644-4b2c-a0de-982e906fabc3
4556480757ANDAWockhardt Limited2007-03-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTIONANDA077942cff1fed3-1f30-4da9-93b4-8eebd0fd88b3
5633230161ANDAApp Pharmaceuticals, Llc2001-09-05KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA075784950b7295-3f68-4027-ac2b-2f7d0f5f8ef9, ccf905ca-e164-4779-9485-2d139c821bad, d1920335-8e45-4960-b6e9-e6f1f9e6820c
6646790757ANDAWockhardt Usa Llc.2007-03-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTIONANDA077942b4b2ee9a-f59d-4c2f-878c-04a870e2a369
7760450107ANDABd Rx Inc.2015-11-02KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA2032423d88cbe6-5230-47aa-80af-0c41283d1f00

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006416041ANDAWest-Ward Pharmaceuticals Corp.2004-07-21KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTIONANDA0757720c2c75c9-ed7b-46a8-9543-429bf2d8f090
2551540368ANDACardinal Health1999-04-26KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION553900480ANDA0752220baa018b-b653-4313-818d-3b0d726df492

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551540134ANDACardinal Health2011-07-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093793ANDA0748020772d6cb-0007-47c1-b3c9-28a1dc71b454
2551546960ANDACardinal Health2011-07-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093793ANDA074802dd489c86-08c0-4457-86f3-c4f36a70276c
3551549366ANDACardinal Health2001-09-05KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION633230161ANDA0757846758cb38-dec8-468f-94e2-613772e39b9a

ketorolac tromethamine 30 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1250210701ANDASagent Pharmaceuticals2014-09-05KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA09106562591551-a644-4b2c-a0de-982e906fabc3
2633230162ANDAApp Pharmaceuticals, Llc2000-10-18KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA075784950b7295-3f68-4027-ac2b-2f7d0f5f8ef9, ccf905ca-e164-4779-9485-2d139c821bad, d1920335-8e45-4960-b6e9-e6f1f9e6820c

1 ml ketorolac tromethamine 30 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690087ANDAPfizer Labs2011-05-11KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTIONANDA0782996d0bc721-390c-4475-9915-d3bcccc60b76
2004093795ANDAHospira, Inc.1997-06-05KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA0748026a77b694-e9a7-417d-b9cc-e700771b6728, 8accbb78-fc64-45d5-69b0-35c23a1d2a2e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416042ANDAWest-Ward Pharmaceuticals Corp.2004-07-21KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTIONANDA0757720c2c75c9-ed7b-46a8-9543-429bf2d8f090

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490753ANDARemedyrepack Inc.2013-06-12, 2014-05-14KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION646790758ANDA0779423711d964-9243-44b8-9747-774efac48272, f3557888-bd32-40fa-9fbc-0873483f7791
2493490837ANDARemedyrepack Inc.2013-06-14, 2013-11-21, 2013-12-13KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION646790758ANDA0779425cec8fe6-0ce7-462d-a123-1ffc4bbd4fdf, 8b4165b7-e2eb-49c6-a106-3191629e0c8d, d68cdee2-4c38-423e-8cb9-b3fa2560486f
3525840795ANDAGeneral Injecatables & Vaccines, Inc2012-04-10KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093795ANDA0748026436dfa0-5f27-456a-83b9-c0485a40d9cc
4551540120ANDACardinal Health2011-07-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093795ANDA074802dd489c86-08c0-4457-86f3-c4f36a70276c
5551540130ANDACardinal Health2011-07-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093795ANDA0748020772d6cb-0007-47c1-b3c9-28a1dc71b454
6551549368ANDACardinal Health2000-10-18KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION633230162ANDA075784f335a030-ffa8-4f42-8166-2f06e036b40d
7617860055ANDARemedyrepack Inc.2015-11-12KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093795ANDA07480200bb52a9-1923-4663-a99c-8cbde1eb0a00
8617860238ANDARemedyrepack Inc.2015-03-25KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION633230162ANDA075784ca7a2141-91c1-4a42-8dd3-b0fcacf87357
9617860369ANDARemedyrepack Inc.2015-07-15KETOROLAC TROMETHAMINEINTRAVENOUSINJECTION, SOLUTION250210701ANDA091065786e4f38-39d8-40ea-97c7-8e21ffc95a39

2 ml ketorolac tromethamine 30 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093796ANDAHospira, Inc.1997-06-05KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA0748026a77b694-e9a7-417d-b9cc-e700771b6728, 8accbb78-fc64-45d5-69b0-35c23a1d2a2e
2760450104ANDABd Rx Inc.2015-11-02KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA2032423d88cbe6-5230-47aa-80af-0c41283d1f00
3760450105ANDABd Rx Inc.2015-11-02KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA2032423d88cbe6-5230-47aa-80af-0c41283d1f00

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006416043ANDAWest-Ward Pharmaceuticals Corp.2004-07-21KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTIONANDA0757720c2c75c9-ed7b-46a8-9543-429bf2d8f090
2551540369ANDACardinal Health1999-04-26KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION553900481ANDA0752220baa018b-b653-4313-818d-3b0d726df492

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490834ANDARemedyrepack Inc.2013-06-14, 2013-11-21KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION646790758ANDA077942082591e3-e542-45ee-b1b6-9d49e8e8259a, b7ba8d5d-e711-4ca1-9596-f4fe00a3fbe9, f4dd9c07-4b8f-476d-b08d-66793c6b5ea1
2521250635ANDARemedyrepack Inc.2013-06-10, 2013-11-21KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION646790758ANDA07794230956e56-52e0-40a5-b273-b9a53f83bbe6, 3adbb63c-b43b-4294-9742-fe1493737bac, 45121ab4-62cd-44c9-8ed8-aaba949a09c5
3525840796ANDAGeneral Injecatables & Vaccines, Inc2012-04-10KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093796ANDA07480236d4f6c4-4946-4baa-8f9d-42a03926eeb7
4548684419ANDAPhysicians Total Care, Inc.2000-11-03KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION646790758ANDA07794263b51e87-a223-4d62-b94e-60adf4872376
5551540149ANDACardinal Health2011-07-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093796ANDA074802dd489c86-08c0-4457-86f3-c4f36a70276c
6551542383ANDACardinal Health2011-07-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093796ANDA0748020772d6cb-0007-47c1-b3c9-28a1dc71b454
7551549375ANDACardinal Health2000-10-18KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION633230162ANDA075784183ca97a-921c-456e-9db4-48f56069a059
8617860082ANDARemedyrepack Inc.2014-10-29KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093796ANDA074802aa37d352-e137-4c49-a312-ecadb1f4fef7
9637390472ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2010-05-03KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004093796ANDA0748027dad59b7-0ae1-4750-9122-9ab103db4bf0

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA074801KETOROLAC TROMETHAMINETrueHOSPIRA INC1997-06-05ANDA074801_001, ANDA074801_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
2ANDA074802KETOROLAC TROMETHAMINEHOSPIRA INC1997-06-05ANDA074802_001, ANDA074802_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
3ANDA074993KETOROLAC TROMETHAMINEHOSPIRA INC1999-01-27ANDA074993_001, ANDA074993_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
4ANDA075222KETOROLAC TROMETHAMINETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1999-04-26ANDA075222_001, ANDA075222_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
5ANDA075228KETOROLAC TROMETHAMINETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1999-04-26ANDA075228_001Ketorolac Prefilled Syringe
Ketorolac Cartridge
6ANDA075230KETOROLAC TROMETHAMINETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1999-10-25ANDA075230_001, ANDA075230_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
7ANDA075299KETOROLAC TROMETHAMINETrueHIKMA MAPLE LTD1999-11-03ANDA075299_001, ANDA075299_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
8ANDA075348KETOROLAC TROMETHAMINETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB2000-11-28ANDA075348_001, ANDA075348_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
9ANDA075626KETOROLAC TROMETHAMINETrueAPOTEX INC2001-07-24ANDA075626_001Ketorolac Prefilled Syringe
Ketorolac Cartridge
10ANDA075631KETOROLAC TROMETHAMINETrueCLARIS PHARMASERVICES2001-06-29ANDA075631_001, ANDA075631_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
11ANDA075772KETOROLAC TROMETHAMINETrueEUROHEALTH INTERNATIONAL SARL2004-07-21ANDA075772_001, ANDA075772_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
12ANDA075784KETOROLAC TROMETHAMINEFRESENIUS KABI USA LLC2002-01-11ANDA075784_001, ANDA075784_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
13ANDA076209KETOROLAC TROMETHAMINETrueAMPHASTAR PHARMACEUTICAL INC2004-07-21ANDA076209_001, ANDA076209_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
14ANDA076271KETOROLAC TROMETHAMINESANDOZ CANADA INC2004-10-06ANDA076271_001, ANDA076271_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
15ANDA076722KETOROLAC TROMETHAMINETrueGLAND PHARMA LTD2004-07-27ANDA076722_001, ANDA076722_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
16ANDA077201KETOROLAC TROMETHAMINETrueAPOTEX INC2005-10-14ANDA077201_001Ketorolac Prefilled Syringe
Ketorolac Cartridge
17ANDA077942KETOROLAC TROMETHAMINEWOCKHARDT LTD2007-03-27ANDA077942_001, ANDA077942_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
18ANDA077943KETOROLAC TROMETHAMINETrueWOCKHARDT LTD2007-03-27ANDA077943_001Ketorolac Prefilled Syringe
Ketorolac Cartridge
19ANDA078145KETOROLAC TROMETHAMINETrueLUITPOLD PHARMACEUTICALS INC2008-01-14ANDA078145_001, ANDA078145_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
20ANDA078299KETOROLAC TROMETHAMINEMYLAN LABORATORIES LTD2007-07-16ANDA078299_001, ANDA078299_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
21ANDA078737KETOROLAC TROMETHAMINETrueSUN PHARMA GLOBAL INC2008-10-06ANDA078737_001, ANDA078737_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
22ANDA091065KETOROLAC TROMETHAMINESAGENT PHARMACEUTICALS INC2013-11-27ANDA091065_001, ANDA091065_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
23ANDA201155KETOROLAC TROMETHAMINEMYLAN LABORATORIES LTD2014-08-04ANDA201155_001, ANDA201155_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
24ANDA203242KETOROLAC TROMETHAMINEBD RX INC2015-10-07ANDA203242_001, ANDA203242_002Ketorolac Prefilled Syringe
Ketorolac Cartridge
25NDA019698TORADOLTrueROCHE PALO ALTO LLC1989-11-30NDA019698_001, NDA019698_002Ketorolac Prefilled Syringe
Ketorolac Cartridge

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074801_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse1997-06-05KETOROLAC TROMETHAMINE
2ANDA074801_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse1997-06-05KETOROLAC TROMETHAMINE
3ANDA074802_001RXKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONTrueAP1997-06-05KETOROLAC TROMETHAMINE
4ANDA074802_002RXKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONTrueAP1997-06-05KETOROLAC TROMETHAMINE
5ANDA074993_001RXKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalseAP1999-01-27KETOROLAC TROMETHAMINE
6ANDA074993_002RXKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalseAP1999-01-27KETOROLAC TROMETHAMINE
7ANDA075222_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse1999-04-26KETOROLAC TROMETHAMINE
8ANDA075222_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse1999-04-26KETOROLAC TROMETHAMINE
9ANDA075228_001discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse1999-04-26KETOROLAC TROMETHAMINE
10ANDA075230_001discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse1999-10-25KETOROLAC TROMETHAMINE
11ANDA075230_002discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse1999-10-25KETOROLAC TROMETHAMINE
12ANDA075299_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse1999-11-03KETOROLAC TROMETHAMINE
13ANDA075299_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse1999-11-03KETOROLAC TROMETHAMINE
14ANDA075348_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse2000-11-28KETOROLAC TROMETHAMINE
15ANDA075348_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2000-11-28KETOROLAC TROMETHAMINE
16ANDA075626_001discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2001-07-24KETOROLAC TROMETHAMINE
17ANDA075631_001discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2001-06-29KETOROLAC TROMETHAMINE
18ANDA075631_002discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse2001-06-29KETOROLAC TROMETHAMINE
19ANDA075772_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse2004-07-21KETOROLAC TROMETHAMINE
20ANDA075772_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2004-07-21KETOROLAC TROMETHAMINE
21ANDA075784_001RXKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalseAP2002-01-11KETOROLAC TROMETHAMINE
22ANDA075784_002RXKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalseAP2002-01-11KETOROLAC TROMETHAMINE
23ANDA076209_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse2004-07-21KETOROLAC TROMETHAMINE
24ANDA076209_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2004-07-21KETOROLAC TROMETHAMINE
25ANDA076271_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse2004-10-06KETOROLAC TROMETHAMINE
26ANDA076271_002RXKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalseAP2004-10-06KETOROLAC TROMETHAMINE
27ANDA076722_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse2004-07-27KETOROLAC TROMETHAMINE
28ANDA076722_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2004-07-27KETOROLAC TROMETHAMINE
29ANDA077201_001discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2005-10-14KETOROLAC TROMETHAMINE
30ANDA077942_001RXKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalseAP2007-03-27KETOROLAC TROMETHAMINE
31ANDA077942_002RXKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalseAP2007-03-27KETOROLAC TROMETHAMINE
32ANDA077943_001discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2007-03-27KETOROLAC TROMETHAMINE
33ANDA078145_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse2008-01-14KETOROLAC TROMETHAMINE
34ANDA078145_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2008-01-14KETOROLAC TROMETHAMINE
35ANDA078299_001RXKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalseAP2007-07-16KETOROLAC TROMETHAMINE
36ANDA078299_002RXKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalseAP2007-07-16KETOROLAC TROMETHAMINE
37ANDA078737_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse2008-10-06KETOROLAC TROMETHAMINE
38ANDA078737_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse2008-10-06KETOROLAC TROMETHAMINE
39ANDA091065_001RXKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalseAP2013-11-27KETOROLAC TROMETHAMINE
40ANDA091065_002RXKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalseAP2013-11-27KETOROLAC TROMETHAMINE
41ANDA201155_001RXKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalseAP2014-08-04KETOROLAC TROMETHAMINE
42ANDA201155_002RXKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalseAP2014-08-04KETOROLAC TROMETHAMINE
43ANDA203242_001RXKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalseAP2015-10-07KETOROLAC TROMETHAMINE
44ANDA203242_002RXKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalseAP2015-10-07KETOROLAC TROMETHAMINE
45NDA019698_001discontinuedKETOROLAC TROMETHAMINE (15MG/ML)INJECTIONFalse1989-11-30TORADOL
46NDA019698_002discontinuedKETOROLAC TROMETHAMINE (30MG/ML)INJECTIONFalse1989-11-30TORADOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100bb52a9-1923-4663-a99c-8cbde1eb0a00 (view SPL)Ketorolac TromethamineprescriptionHuman PrescriptionRemedyrepack Inc.2015-11-121617860055
20772d6cb-0007-47c1-b3c9-28a1dc71b454 (view SPL)Ketorolac TromethamineprescriptionHuman PrescriptionCardinal HealthREPACK2014-08-217551540130, 551540134, 551542383
3082591e3-e542-45ee-b1b6-9d49e8e8259a (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-211493490834
40baa018b-b653-4313-818d-3b0d726df492 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-202551540368, 551540369
50c2c75c9-ed7b-46a8-9543-429bf2d8f090 (view SPL)Ketorolac Tromethamine Injection, USP Rx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-10-181006416041, 006416042, 006416043
6183ca97a-921c-456e-9db4-48f56069a059 (view SPL)Ketorolac Tromethamine Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-201551549375
730956e56-52e0-40a5-b273-b9a53f83bbe6 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-211521250635
836d4f6c4-4946-4baa-8f9d-42a03926eeb7 (view SPL)Ketorolac Tromethamine 30 mg/mL Injection, USP 2 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-04-112525840796
93711d964-9243-44b8-9747-774efac48272 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-05-141493490753
103adbb63c-b43b-4294-9742-fe1493737bac (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-211521250635
113d88cbe6-5230-47aa-80af-0c41283d1f00 (view SPL)Ketorolac TromethamineprescriptionHuman PrescriptionBd Rx Inc.2015-02-066760450104, 760450105, 760450107
1245121ab4-62cd-44c9-8ed8-aaba949a09c5 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101521250635
135cec8fe6-0ce7-462d-a123-1ffc4bbd4fdf (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-211493490837
1462591551-a644-4b2c-a0de-982e906fabc3 (view SPL)Ketorolac Tromethamine Injection, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2015-07-216250210700, 250210701
1563b51e87-a223-4d62-b94e-60adf4872376 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-12-292548684419
166436dfa0-5f27-456a-83b9-c0485a40d9cc (view SPL)Ketorolac Tromethamine Injection, USPFOR IV/IM USE (15 mg and 30 mg)FOR IM USE ONLY (60 mg)Rx onlyprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-10-093525840795
176758cb38-dec8-468f-94e2-613772e39b9a (view SPL)Ketorolac Tromethamine Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-10-151551549366
186a77b694-e9a7-417d-b9cc-e700771b6728 (view SPL)Ketorolac TromethamineprescriptionHuman PrescriptionHospira, Inc.2014-05-091004093793, 004093795, 004093796
196d0bc721-390c-4475-9915-d3bcccc60b76 (view SPL)ketorolac tromethamine injection USPprescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE2012-07-253000690085, 000690087
20786e4f38-39d8-40ea-97c7-8e21ffc95a39 (view SPL)Ketorolac Tromethamine Injection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-07-151617860369
217dad59b7-0ae1-4750-9122-9ab103db4bf0 (view SPL)Ketorolac Tromethamine Injection, USP60 mg (30 mg/mL)I.V./I.M.prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationMANUFACTURE, REPACK2010-05-031637390472
228accbb78-fc64-45d5-69b0-35c23a1d2a2e (view SPL)Ketorolac TromethamineprescriptionHuman PrescriptionHospira, Inc.2015-08-0715004093793, 004093795, 004093796
238b4165b7-e2eb-49c6-a106-3191629e0c8d (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-131493490837
24950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 (view SPL)Ketorolac Tromethamine Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-12-231633230161, 633230162
25aa37d352-e137-4c49-a312-ecadb1f4fef7 (view SPL)KetorolacTromethamineprescriptionHuman PrescriptionRemedyrepack Inc.2014-10-291617860082
26b4b2ee9a-f59d-4c2f-878c-04a870e2a369 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionWockhardt Usa Llc.manufacture2011-10-211646790757, 646790758
27b7ba8d5d-e711-4ca1-9596-f4fe00a3fbe9 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-211493490834
28ca7a2141-91c1-4a42-8dd3-b0fcacf87357 (view SPL)Ketorolac Tromethamine Injection USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-03-251617860238
29ccf905ca-e164-4779-9485-2d139c821bad (view SPL)Ketorolac Tromethamine Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-09-301633230161, 633230162
30cff1fed3-1f30-4da9-93b4-8eebd0fd88b3 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionWockhardt Limitedmanufacture2011-10-182556480757, 556480758
31d1920335-8e45-4960-b6e9-e6f1f9e6820c (view SPL)Ketorolac Tromethamine Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-09-083633230161, 633230162
32d68cdee2-4c38-423e-8cb9-b3fa2560486f (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-141493490837
33dd489c86-08c0-4457-86f3-c4f36a70276c (view SPL)Ketorolac TromethamineprescriptionHuman PrescriptionCardinal HealthREPACK2015-08-176551540120, 551540149, 551546960
34f335a030-ffa8-4f42-8166-2f06e036b40d (view SPL)Ketorolac Tromethamine Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-201551549368
35f3557888-bd32-40fa-9fbc-0873483f7791 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-121493490753
36f4dd9c07-4b8f-476d-b08d-66793c6b5ea1 (view SPL)KETOROLAC TROMETHAMINE INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-141493490834

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