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)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000690085 | ANDA | Pfizer Labs | 2011-05-11 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | ANDA078299 | 6d0bc721-390c-4475-9915-d3bcccc60b76 |
| 2 | 004093793 | ANDA | Hospira, Inc. | 1997-06-05 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA074802 | 6a77b694-e9a7-417d-b9cc-e700771b6728, 8accbb78-fc64-45d5-69b0-35c23a1d2a2e |
| 3 | 250210700 | ANDA | Sagent Pharmaceuticals | 2014-09-05 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA091065 | 62591551-a644-4b2c-a0de-982e906fabc3 |
| 4 | 556480757 | ANDA | Wockhardt Limited | 2007-03-27 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | ANDA077942 | cff1fed3-1f30-4da9-93b4-8eebd0fd88b3 |
| 5 | 633230161 | ANDA | App Pharmaceuticals, Llc | 2001-09-05 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA075784 | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9, ccf905ca-e164-4779-9485-2d139c821bad, d1920335-8e45-4960-b6e9-e6f1f9e6820c |
| 6 | 646790757 | ANDA | Wockhardt Usa Llc. | 2007-03-27 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | ANDA077942 | b4b2ee9a-f59d-4c2f-878c-04a870e2a369 |
| 7 | 760450107 | ANDA | Bd Rx Inc. | 2015-11-02 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA203242 | 3d88cbe6-5230-47aa-80af-0c41283d1f00 |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 006416041 | ANDA | West-Ward Pharmaceuticals Corp. | 2004-07-21 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | ANDA075772 | 0c2c75c9-ed7b-46a8-9543-429bf2d8f090 | |
| 2 | 551540368 | ANDA | Cardinal Health | 1999-04-26 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 553900480 | ANDA075222 | 0baa018b-b653-4313-818d-3b0d726df492 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 551540134 | ANDA | Cardinal Health | 2011-07-27 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093793 | ANDA074802 | 0772d6cb-0007-47c1-b3c9-28a1dc71b454 |
| 2 | 551546960 | ANDA | Cardinal Health | 2011-07-27 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093793 | ANDA074802 | dd489c86-08c0-4457-86f3-c4f36a70276c |
| 3 | 551549366 | ANDA | Cardinal Health | 2001-09-05 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 633230161 | ANDA075784 | 6758cb38-dec8-468f-94e2-613772e39b9a |
ketorolac tromethamine 30 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 250210701 | ANDA | Sagent Pharmaceuticals | 2014-09-05 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA091065 | 62591551-a644-4b2c-a0de-982e906fabc3 |
| 2 | 633230162 | ANDA | App Pharmaceuticals, Llc | 2000-10-18 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA075784 | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9, ccf905ca-e164-4779-9485-2d139c821bad, d1920335-8e45-4960-b6e9-e6f1f9e6820c |
1 ml ketorolac tromethamine 30 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000690087 | ANDA | Pfizer Labs | 2011-05-11 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | ANDA078299 | 6d0bc721-390c-4475-9915-d3bcccc60b76 |
| 2 | 004093795 | ANDA | Hospira, Inc. | 1997-06-05 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA074802 | 6a77b694-e9a7-417d-b9cc-e700771b6728, 8accbb78-fc64-45d5-69b0-35c23a1d2a2e |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 006416042 | ANDA | West-Ward Pharmaceuticals Corp. | 2004-07-21 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | ANDA075772 | 0c2c75c9-ed7b-46a8-9543-429bf2d8f090 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 493490753 | ANDA | Remedyrepack Inc. | 2013-06-12, 2014-05-14 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | 646790758 | ANDA077942 | 3711d964-9243-44b8-9747-774efac48272, f3557888-bd32-40fa-9fbc-0873483f7791 |
| 2 | 493490837 | ANDA | Remedyrepack Inc. | 2013-06-14, 2013-11-21, 2013-12-13 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | 646790758 | ANDA077942 | 5cec8fe6-0ce7-462d-a123-1ffc4bbd4fdf, 8b4165b7-e2eb-49c6-a106-3191629e0c8d, d68cdee2-4c38-423e-8cb9-b3fa2560486f |
| 3 | 525840795 | ANDA | General Injecatables & Vaccines, Inc | 2012-04-10 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093795 | ANDA074802 | 6436dfa0-5f27-456a-83b9-c0485a40d9cc |
| 4 | 551540120 | ANDA | Cardinal Health | 2011-07-27 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093795 | ANDA074802 | dd489c86-08c0-4457-86f3-c4f36a70276c |
| 5 | 551540130 | ANDA | Cardinal Health | 2011-07-27 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093795 | ANDA074802 | 0772d6cb-0007-47c1-b3c9-28a1dc71b454 |
| 6 | 551549368 | ANDA | Cardinal Health | 2000-10-18 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 633230162 | ANDA075784 | f335a030-ffa8-4f42-8166-2f06e036b40d |
| 7 | 617860055 | ANDA | Remedyrepack Inc. | 2015-11-12 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093795 | ANDA074802 | 00bb52a9-1923-4663-a99c-8cbde1eb0a00 |
| 8 | 617860238 | ANDA | Remedyrepack Inc. | 2015-03-25 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 633230162 | ANDA075784 | ca7a2141-91c1-4a42-8dd3-b0fcacf87357 |
| 9 | 617860369 | ANDA | Remedyrepack Inc. | 2015-07-15 | KETOROLAC TROMETHAMINE | INTRAVENOUS | INJECTION, SOLUTION | 250210701 | ANDA091065 | 786e4f38-39d8-40ea-97c7-8e21ffc95a39 |
2 ml ketorolac tromethamine 30 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004093796 | ANDA | Hospira, Inc. | 1997-06-05 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA074802 | 6a77b694-e9a7-417d-b9cc-e700771b6728, 8accbb78-fc64-45d5-69b0-35c23a1d2a2e |
| 2 | 760450104 | ANDA | Bd Rx Inc. | 2015-11-02 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA203242 | 3d88cbe6-5230-47aa-80af-0c41283d1f00 |
| 3 | 760450105 | ANDA | Bd Rx Inc. | 2015-11-02 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA203242 | 3d88cbe6-5230-47aa-80af-0c41283d1f00 |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 006416043 | ANDA | West-Ward Pharmaceuticals Corp. | 2004-07-21 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | ANDA075772 | 0c2c75c9-ed7b-46a8-9543-429bf2d8f090 | |
| 2 | 551540369 | ANDA | Cardinal Health | 1999-04-26 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 553900481 | ANDA075222 | 0baa018b-b653-4313-818d-3b0d726df492 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 493490834 | ANDA | Remedyrepack Inc. | 2013-06-14, 2013-11-21 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | 646790758 | ANDA077942 | 082591e3-e542-45ee-b1b6-9d49e8e8259a, b7ba8d5d-e711-4ca1-9596-f4fe00a3fbe9, f4dd9c07-4b8f-476d-b08d-66793c6b5ea1 |
| 2 | 521250635 | ANDA | Remedyrepack Inc. | 2013-06-10, 2013-11-21 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | 646790758 | ANDA077942 | 30956e56-52e0-40a5-b273-b9a53f83bbe6, 3adbb63c-b43b-4294-9742-fe1493737bac, 45121ab4-62cd-44c9-8ed8-aaba949a09c5 |
| 3 | 525840796 | ANDA | General Injecatables & Vaccines, Inc | 2012-04-10 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093796 | ANDA074802 | 36d4f6c4-4946-4baa-8f9d-42a03926eeb7 |
| 4 | 548684419 | ANDA | Physicians Total Care, Inc. | 2000-11-03 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION | 646790758 | ANDA077942 | 63b51e87-a223-4d62-b94e-60adf4872376 |
| 5 | 551540149 | ANDA | Cardinal Health | 2011-07-27 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093796 | ANDA074802 | dd489c86-08c0-4457-86f3-c4f36a70276c |
| 6 | 551542383 | ANDA | Cardinal Health | 2011-07-27 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093796 | ANDA074802 | 0772d6cb-0007-47c1-b3c9-28a1dc71b454 |
| 7 | 551549375 | ANDA | Cardinal Health | 2000-10-18 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 633230162 | ANDA075784 | 183ca97a-921c-456e-9db4-48f56069a059 |
| 8 | 617860082 | ANDA | Remedyrepack Inc. | 2014-10-29 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093796 | ANDA074802 | aa37d352-e137-4c49-a312-ecadb1f4fef7 |
| 9 | 637390472 | ANDA | Mckesson Packaging Services A Business Unit Of Mckesson Corporation | 2010-05-03 | KETOROLAC TROMETHAMINE | INTRAMUSCULAR | INJECTION, SOLUTION | 004093796 | ANDA074802 | 7dad59b7-0ae1-4750-9122-9ab103db4bf0 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA074801 | KETOROLAC TROMETHAMINE | True | HOSPIRA INC | 1997-06-05 | ANDA074801_001, ANDA074801_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 2 | ANDA074802 | KETOROLAC TROMETHAMINE | HOSPIRA INC | 1997-06-05 | ANDA074802_001, ANDA074802_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge | |
| 3 | ANDA074993 | KETOROLAC TROMETHAMINE | HOSPIRA INC | 1999-01-27 | ANDA074993_001, ANDA074993_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge | |
| 4 | ANDA075222 | KETOROLAC TROMETHAMINE | True | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 1999-04-26 | ANDA075222_001, ANDA075222_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 5 | ANDA075228 | KETOROLAC TROMETHAMINE | True | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 1999-04-26 | ANDA075228_001 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 6 | ANDA075230 | KETOROLAC TROMETHAMINE | True | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 1999-10-25 | ANDA075230_001, ANDA075230_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 7 | ANDA075299 | KETOROLAC TROMETHAMINE | True | HIKMA MAPLE LTD | 1999-11-03 | ANDA075299_001, ANDA075299_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 8 | ANDA075348 | KETOROLAC TROMETHAMINE | True | APOTHECON INC DIV BRISTOL MYERS SQUIBB | 2000-11-28 | ANDA075348_001, ANDA075348_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 9 | ANDA075626 | KETOROLAC TROMETHAMINE | True | APOTEX INC | 2001-07-24 | ANDA075626_001 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 10 | ANDA075631 | KETOROLAC TROMETHAMINE | True | CLARIS PHARMASERVICES | 2001-06-29 | ANDA075631_001, ANDA075631_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 11 | ANDA075772 | KETOROLAC TROMETHAMINE | True | EUROHEALTH INTERNATIONAL SARL | 2004-07-21 | ANDA075772_001, ANDA075772_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 12 | ANDA075784 | KETOROLAC TROMETHAMINE | FRESENIUS KABI USA LLC | 2002-01-11 | ANDA075784_001, ANDA075784_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge | |
| 13 | ANDA076209 | KETOROLAC TROMETHAMINE | True | AMPHASTAR PHARMACEUTICAL INC | 2004-07-21 | ANDA076209_001, ANDA076209_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 14 | ANDA076271 | KETOROLAC TROMETHAMINE | SANDOZ CANADA INC | 2004-10-06 | ANDA076271_001, ANDA076271_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge | |
| 15 | ANDA076722 | KETOROLAC TROMETHAMINE | True | GLAND PHARMA LTD | 2004-07-27 | ANDA076722_001, ANDA076722_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 16 | ANDA077201 | KETOROLAC TROMETHAMINE | True | APOTEX INC | 2005-10-14 | ANDA077201_001 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 17 | ANDA077942 | KETOROLAC TROMETHAMINE | WOCKHARDT LTD | 2007-03-27 | ANDA077942_001, ANDA077942_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge | |
| 18 | ANDA077943 | KETOROLAC TROMETHAMINE | True | WOCKHARDT LTD | 2007-03-27 | ANDA077943_001 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 19 | ANDA078145 | KETOROLAC TROMETHAMINE | True | LUITPOLD PHARMACEUTICALS INC | 2008-01-14 | ANDA078145_001, ANDA078145_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 20 | ANDA078299 | KETOROLAC TROMETHAMINE | MYLAN LABORATORIES LTD | 2007-07-16 | ANDA078299_001, ANDA078299_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge | |
| 21 | ANDA078737 | KETOROLAC TROMETHAMINE | True | SUN PHARMA GLOBAL INC | 2008-10-06 | ANDA078737_001, ANDA078737_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
| 22 | ANDA091065 | KETOROLAC TROMETHAMINE | SAGENT PHARMACEUTICALS INC | 2013-11-27 | ANDA091065_001, ANDA091065_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge | |
| 23 | ANDA201155 | KETOROLAC TROMETHAMINE | MYLAN LABORATORIES LTD | 2014-08-04 | ANDA201155_001, ANDA201155_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge | |
| 24 | ANDA203242 | KETOROLAC TROMETHAMINE | BD RX INC | 2015-10-07 | ANDA203242_001, ANDA203242_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge | |
| 25 | NDA019698 | TORADOL | True | ROCHE PALO ALTO LLC | 1989-11-30 | NDA019698_001, NDA019698_002 | Ketorolac Prefilled Syringe Ketorolac Cartridge |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA074801_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 1997-06-05 | KETOROLAC TROMETHAMINE | |
| 2 | ANDA074801_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 1997-06-05 | KETOROLAC TROMETHAMINE | |
| 3 | ANDA074802_001 | RX | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | True | AP | 1997-06-05 | KETOROLAC TROMETHAMINE |
| 4 | ANDA074802_002 | RX | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | True | AP | 1997-06-05 | KETOROLAC TROMETHAMINE |
| 5 | ANDA074993_001 | RX | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | AP | 1999-01-27 | KETOROLAC TROMETHAMINE |
| 6 | ANDA074993_002 | RX | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | AP | 1999-01-27 | KETOROLAC TROMETHAMINE |
| 7 | ANDA075222_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 1999-04-26 | KETOROLAC TROMETHAMINE | |
| 8 | ANDA075222_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 1999-04-26 | KETOROLAC TROMETHAMINE | |
| 9 | ANDA075228_001 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 1999-04-26 | KETOROLAC TROMETHAMINE | |
| 10 | ANDA075230_001 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 1999-10-25 | KETOROLAC TROMETHAMINE | |
| 11 | ANDA075230_002 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 1999-10-25 | KETOROLAC TROMETHAMINE | |
| 12 | ANDA075299_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 1999-11-03 | KETOROLAC TROMETHAMINE | |
| 13 | ANDA075299_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 1999-11-03 | KETOROLAC TROMETHAMINE | |
| 14 | ANDA075348_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 2000-11-28 | KETOROLAC TROMETHAMINE | |
| 15 | ANDA075348_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2000-11-28 | KETOROLAC TROMETHAMINE | |
| 16 | ANDA075626_001 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2001-07-24 | KETOROLAC TROMETHAMINE | |
| 17 | ANDA075631_001 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2001-06-29 | KETOROLAC TROMETHAMINE | |
| 18 | ANDA075631_002 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 2001-06-29 | KETOROLAC TROMETHAMINE | |
| 19 | ANDA075772_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 2004-07-21 | KETOROLAC TROMETHAMINE | |
| 20 | ANDA075772_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2004-07-21 | KETOROLAC TROMETHAMINE | |
| 21 | ANDA075784_001 | RX | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | AP | 2002-01-11 | KETOROLAC TROMETHAMINE |
| 22 | ANDA075784_002 | RX | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | AP | 2002-01-11 | KETOROLAC TROMETHAMINE |
| 23 | ANDA076209_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 2004-07-21 | KETOROLAC TROMETHAMINE | |
| 24 | ANDA076209_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2004-07-21 | KETOROLAC TROMETHAMINE | |
| 25 | ANDA076271_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 2004-10-06 | KETOROLAC TROMETHAMINE | |
| 26 | ANDA076271_002 | RX | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | AP | 2004-10-06 | KETOROLAC TROMETHAMINE |
| 27 | ANDA076722_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 2004-07-27 | KETOROLAC TROMETHAMINE | |
| 28 | ANDA076722_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2004-07-27 | KETOROLAC TROMETHAMINE | |
| 29 | ANDA077201_001 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2005-10-14 | KETOROLAC TROMETHAMINE | |
| 30 | ANDA077942_001 | RX | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | AP | 2007-03-27 | KETOROLAC TROMETHAMINE |
| 31 | ANDA077942_002 | RX | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | AP | 2007-03-27 | KETOROLAC TROMETHAMINE |
| 32 | ANDA077943_001 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2007-03-27 | KETOROLAC TROMETHAMINE | |
| 33 | ANDA078145_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 2008-01-14 | KETOROLAC TROMETHAMINE | |
| 34 | ANDA078145_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2008-01-14 | KETOROLAC TROMETHAMINE | |
| 35 | ANDA078299_001 | RX | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | AP | 2007-07-16 | KETOROLAC TROMETHAMINE |
| 36 | ANDA078299_002 | RX | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | AP | 2007-07-16 | KETOROLAC TROMETHAMINE |
| 37 | ANDA078737_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 2008-10-06 | KETOROLAC TROMETHAMINE | |
| 38 | ANDA078737_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 2008-10-06 | KETOROLAC TROMETHAMINE | |
| 39 | ANDA091065_001 | RX | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | AP | 2013-11-27 | KETOROLAC TROMETHAMINE |
| 40 | ANDA091065_002 | RX | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | AP | 2013-11-27 | KETOROLAC TROMETHAMINE |
| 41 | ANDA201155_001 | RX | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | AP | 2014-08-04 | KETOROLAC TROMETHAMINE |
| 42 | ANDA201155_002 | RX | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | AP | 2014-08-04 | KETOROLAC TROMETHAMINE |
| 43 | ANDA203242_001 | RX | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | AP | 2015-10-07 | KETOROLAC TROMETHAMINE |
| 44 | ANDA203242_002 | RX | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | AP | 2015-10-07 | KETOROLAC TROMETHAMINE |
| 45 | NDA019698_001 | discontinued | KETOROLAC TROMETHAMINE (15MG/ML) | INJECTION | False | 1989-11-30 | TORADOL | |
| 46 | NDA019698_002 | discontinued | KETOROLAC TROMETHAMINE (30MG/ML) | INJECTION | False | 1989-11-30 | TORADOL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 00bb52a9-1923-4663-a99c-8cbde1eb0a00 (view SPL) | Ketorolac Tromethamine | prescription | Human Prescription | Remedyrepack Inc. | 2015-11-12 | 1 | 617860055 | |
| 2 | 0772d6cb-0007-47c1-b3c9-28a1dc71b454 (view SPL) | Ketorolac Tromethamine | prescription | Human Prescription | Cardinal Health | REPACK | 2014-08-21 | 7 | 551540130, 551540134, 551542383 |
| 3 | 082591e3-e542-45ee-b1b6-9d49e8e8259a (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-11-21 | 1 | 493490834 | |
| 4 | 0baa018b-b653-4313-818d-3b0d726df492 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Cardinal Health | REPACK | 2013-05-20 | 2 | 551540368, 551540369 |
| 5 | 0c2c75c9-ed7b-46a8-9543-429bf2d8f090 (view SPL) | Ketorolac Tromethamine Injection, USP Rx only | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | ANALYSIS, LABEL, MANUFACTURE | 2011-10-18 | 1 | 006416041, 006416042, 006416043 |
| 6 | 183ca97a-921c-456e-9db4-48f56069a059 (view SPL) | Ketorolac Tromethamine Injection USP | prescription | Human Prescription | Cardinal Health | REPACK | 2013-05-20 | 1 | 551549375 |
| 7 | 30956e56-52e0-40a5-b273-b9a53f83bbe6 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-11-21 | 1 | 521250635 | |
| 8 | 36d4f6c4-4946-4baa-8f9d-42a03926eeb7 (view SPL) | Ketorolac Tromethamine 30 mg/mL Injection, USP 2 mL Single Dose Vial | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2012-04-11 | 2 | 525840796 | |
| 9 | 3711d964-9243-44b8-9747-774efac48272 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2014-05-14 | 1 | 493490753 | |
| 10 | 3adbb63c-b43b-4294-9742-fe1493737bac (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-11-21 | 1 | 521250635 | |
| 11 | 3d88cbe6-5230-47aa-80af-0c41283d1f00 (view SPL) | Ketorolac Tromethamine | prescription | Human Prescription | Bd Rx Inc. | 2015-02-06 | 6 | 760450104, 760450105, 760450107 | |
| 12 | 45121ab4-62cd-44c9-8ed8-aaba949a09c5 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-06-10 | 1 | 521250635 | |
| 13 | 5cec8fe6-0ce7-462d-a123-1ffc4bbd4fdf (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-11-21 | 1 | 493490837 | |
| 14 | 62591551-a644-4b2c-a0de-982e906fabc3 (view SPL) | Ketorolac Tromethamine Injection, USP | prescription | Human Prescription | Sagent Pharmaceuticals | 2015-07-21 | 6 | 250210700, 250210701 | |
| 15 | 63b51e87-a223-4d62-b94e-60adf4872376 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2011-12-29 | 2 | 548684419 |
| 16 | 6436dfa0-5f27-456a-83b9-c0485a40d9cc (view SPL) | Ketorolac Tromethamine Injection, USPFOR IV/IM USE (15 mg and 30 mg)FOR IM USE ONLY (60 mg)Rx only | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2013-10-09 | 3 | 525840795 | |
| 17 | 6758cb38-dec8-468f-94e2-613772e39b9a (view SPL) | Ketorolac Tromethamine Injection USP | prescription | Human Prescription | Cardinal Health | REPACK | 2015-10-15 | 1 | 551549366 |
| 18 | 6a77b694-e9a7-417d-b9cc-e700771b6728 (view SPL) | Ketorolac Tromethamine | prescription | Human Prescription | Hospira, Inc. | 2014-05-09 | 1 | 004093793, 004093795, 004093796 | |
| 19 | 6d0bc721-390c-4475-9915-d3bcccc60b76 (view SPL) | ketorolac tromethamine injection USP | prescription | Human Prescription | Pfizer Labs | ANALYSIS, MANUFACTURE | 2012-07-25 | 3 | 000690085, 000690087 |
| 20 | 786e4f38-39d8-40ea-97c7-8e21ffc95a39 (view SPL) | Ketorolac Tromethamine Injection, USP | prescription | Human Prescription | Remedyrepack Inc. | 2015-07-15 | 1 | 617860369 | |
| 21 | 7dad59b7-0ae1-4750-9122-9ab103db4bf0 (view SPL) | Ketorolac Tromethamine Injection, USP60 mg (30 mg/mL)I.V./I.M. | prescription | Human Prescription | Mckesson Packaging Services A Business Unit Of Mckesson Corporation | MANUFACTURE, REPACK | 2010-05-03 | 1 | 637390472 |
| 22 | 8accbb78-fc64-45d5-69b0-35c23a1d2a2e (view SPL) | Ketorolac Tromethamine | prescription | Human Prescription | Hospira, Inc. | 2015-08-07 | 15 | 004093793, 004093795, 004093796 | |
| 23 | 8b4165b7-e2eb-49c6-a106-3191629e0c8d (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-12-13 | 1 | 493490837 | |
| 24 | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 (view SPL) | Ketorolac Tromethamine Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2014-12-23 | 1 | 633230161, 633230162 |
| 25 | aa37d352-e137-4c49-a312-ecadb1f4fef7 (view SPL) | KetorolacTromethamine | prescription | Human Prescription | Remedyrepack Inc. | 2014-10-29 | 1 | 617860082 | |
| 26 | b4b2ee9a-f59d-4c2f-878c-04a870e2a369 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Wockhardt Usa Llc. | manufacture | 2011-10-21 | 1 | 646790757, 646790758 |
| 27 | b7ba8d5d-e711-4ca1-9596-f4fe00a3fbe9 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-11-21 | 1 | 493490834 | |
| 28 | ca7a2141-91c1-4a42-8dd3-b0fcacf87357 (view SPL) | Ketorolac Tromethamine Injection USP | prescription | Human Prescription | Remedyrepack Inc. | 2015-03-25 | 1 | 617860238 | |
| 29 | ccf905ca-e164-4779-9485-2d139c821bad (view SPL) | Ketorolac Tromethamine Injection, USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-09-30 | 1 | 633230161, 633230162 |
| 30 | cff1fed3-1f30-4da9-93b4-8eebd0fd88b3 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Wockhardt Limited | manufacture | 2011-10-18 | 2 | 556480757, 556480758 |
| 31 | d1920335-8e45-4960-b6e9-e6f1f9e6820c (view SPL) | Ketorolac Tromethamine Injection, USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-09-08 | 3 | 633230161, 633230162 |
| 32 | d68cdee2-4c38-423e-8cb9-b3fa2560486f (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-06-14 | 1 | 493490837 | |
| 33 | dd489c86-08c0-4457-86f3-c4f36a70276c (view SPL) | Ketorolac Tromethamine | prescription | Human Prescription | Cardinal Health | REPACK | 2015-08-17 | 6 | 551540120, 551540149, 551546960 |
| 34 | f335a030-ffa8-4f42-8166-2f06e036b40d (view SPL) | Ketorolac Tromethamine Injection USP | prescription | Human Prescription | Cardinal Health | REPACK | 2013-05-20 | 1 | 551549368 |
| 35 | f3557888-bd32-40fa-9fbc-0873483f7791 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-06-12 | 1 | 493490753 | |
| 36 | f4dd9c07-4b8f-476d-b08d-66793c6b5ea1 (view SPL) | KETOROLAC TROMETHAMINE INJECTION USP | prescription | Human Prescription | Remedyrepack Inc. | 2013-06-14 | 1 | 493490834 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII