FDA — authorised 16 May 1997
- Application: ANDA074761
- Marketing authorisation holder: MYLAN
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ketorolac at high dose in United States
FDA authorised Ketorolac at high dose on 16 May 1997
Marketing authorisations
FDA — authorised 16 May 1997
- Application: ANDA074754
- Marketing authorisation holder: TEVA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1997
- Application: ANDA074955
- Marketing authorisation holder: WATSON LABS
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 1997
- Application: NDA020811
- Marketing authorisation holder: ALLERGAN
- Local brand name: ACULAR PRESERVATIVE FREE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 27 January 1999
- Application: ANDA074993
- Marketing authorisation holder: HOSPIRA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 April 1999
- Application: ANDA075228
- Marketing authorisation holder: HIKMA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 April 1999
- Application: ANDA075222
- Marketing authorisation holder: HIKMA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 June 1999
- Application: ANDA075284
- Marketing authorisation holder: PLIVA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 1999
- Application: ANDA075230
- Marketing authorisation holder: BEDFORD
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 November 1999
- Application: ANDA075299
- Marketing authorisation holder: HIKMA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 November 2000
- Application: ANDA075348
- Marketing authorisation holder: APOTHECON
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 2001
- Application: ANDA075631
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 July 2001
- Application: ANDA075626
- Marketing authorisation holder: APOTEX INC
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 January 2002
- Application: ANDA075784
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 July 2004
- Application: ANDA076209
- Marketing authorisation holder: AMPHASTAR PHARM
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 July 2004
- Application: ANDA075772
- Marketing authorisation holder: HIKMA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 October 2004
- Application: ANDA076271
- Marketing authorisation holder: SANDOZ
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 October 2005
- Application: ANDA077201
- Marketing authorisation holder: APOTEX INC
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 March 2007
- Application: ANDA077943
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 March 2007
- Application: ANDA077942
- Marketing authorisation holder: APOTEX
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 July 2007
- Application: ANDA078299
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 January 2008
- Application: ANDA078145
- Marketing authorisation holder: LUITPOLD
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 October 2008
- Application: ANDA078737
- Marketing authorisation holder: SUN PHARM
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 November 2009
- Application: ANDA076583
- Marketing authorisation holder: SANDOZ
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 November 2009
- Application: ANDA076109
- Marketing authorisation holder: APOTEX
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 November 2009
- Application: ANDA078721
- Marketing authorisation holder: SANDOZ
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 November 2009
- Application: ANDA078399
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 November 2009
- Application: ANDA078434
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 November 2009
- Application: ANDA090017
- Marketing authorisation holder: SUN PHARM
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 February 2014
- Application: ANDA203376
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 August 2014
- Application: ANDA201155
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 October 2015
- Application: ANDA203242
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 November 2016
- Application: ANDA204216
- Marketing authorisation holder: GLAND
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 September 2017
- Application: ANDA209900
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 November 2018
- Application: ANDA205191
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 April 2019
- Application: ANDA203410
- Marketing authorisation holder: MICRO LABS LTD INDIA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 1 July 2019
- Application: ANDA210183
- Marketing authorisation holder: LUPIN
- Local brand name: KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
- Indication: SOLUTION — IRRIGATION
- Status: approved
FDA — authorised 20 August 2020
- Application: ANDA211445
- Marketing authorisation holder: NEPHRON
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 October 2020
- Application: ANDA212939
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 December 2020
- Application: ANDA205190
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 23 March 2022
- Application: ANDA215788
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 2022
- Application: ANDA216651
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 October 2022
- Application: ANDA216407
- Marketing authorisation holder: ATNAHS PHARMA US
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 October 2022
- Application: ANDA217038
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 2022
- Application: ANDA214456
- Marketing authorisation holder: ALEMBIC
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 February 2023
- Application: ANDA216759
- Marketing authorisation holder: BIONPHARMA
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2023
- Application: ANDA215745
- Marketing authorisation holder: LEADING
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2023
- Application: ANDA217789
- Marketing authorisation holder: CAPLIN
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 June 2023
- Application: ANDA217166
- Marketing authorisation holder: ASPIRO
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 March 2024
- Application: ANDA218204
- Marketing authorisation holder: CAPLIN
- Local brand name: KETOROLAC TROMETHAMINE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
Frequently asked questions
Is Ketorolac at high dose approved in United States?
Yes. FDA authorised it on 16 May 1997; FDA authorised it on 16 May 1997; FDA authorised it on 19 September 1997.
Who is the marketing authorisation holder for Ketorolac at high dose in United States?
MYLAN holds the US marketing authorisation.