Ketorolac Cartridge

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-08-10)
Oldest Current Product
1999-01-27
License(s)
ANDA
RxNORM
CARTRIDGE\KETOROLAC
FDAOB
INJECTION\INJECTION\KETOROLAC TROMETHAMINE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\KETOROLAC TROMETHAMINE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\KETOROLAC

product(s) by strength(s)

1 ml ketorolac tromethamine 15 mg/ml cartridge

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092288ANDAHospira, Inc.1999-01-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA07499342e7d810-ab12-4487-5082-b2a050e75e61, 499fc2bc-3311-4caa-288a-327d40eb26d9

ketorolac tromethamine 30 mg/ml cartridge

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092287ANDAHospira, Inc.1999-01-27, 2012-04-30KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTIONANDA07499342e7d810-ab12-4487-5082-b2a050e75e61, 499fc2bc-3311-4caa-288a-327d40eb26d9, a036819d-d0d8-4d95-93c9-d362d943ec2d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950588ANDARebel Distributors Corp1999-01-27KETOROLAC TROMETHAMINEINTRAMUSCULARINJECTION, SOLUTION004092287ANDA07499331da4540-1589-492c-8be6-382179e8ece2

application(s)

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

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)
131da4540-1589-492c-8be6-382179e8ece2 (view SPL)Ketorolac TromethamineInjection, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-171216950588
242e7d810-ab12-4487-5082-b2a050e75e61 (view SPL)Ketorolac TromethamineprescriptionHuman PrescriptionHospira, Inc.2015-08-1014004092287, 004092288
3499fc2bc-3311-4caa-288a-327d40eb26d9 (view SPL)Ketorolac Tromethamine Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-08-1014004092287, 004092288
4a036819d-d0d8-4d95-93c9-d362d943ec2d (view SPL)Ketorolac TromethamineprescriptionHuman PrescriptionHospira, Inc.2015-08-0715004092287

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