FDA — authorised 21 December 1960
- Application: NDA012674
- Marketing authorisation holder: ASPEN GLOBAL INC
- Local brand name: HEXADROL
- Indication: ELIXIR — ORAL
- Status: approved
🇺🇸 Cohort A1 & A2: KTX-1001 in United States
FDA authorised Cohort A1 & A2: KTX-1001 on 21 December 1960
Marketing authorisations
FDA — authorised 20 April 1962
- Application: NDA012675
- Marketing authorisation holder: ASPEN GLOBAL INC
- Local brand name: HEXADROL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 October 1971
- Application: ANDA080399
- Marketing authorisation holder: PRASCO
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 May 1973
- Application: ANDA080968
- Marketing authorisation holder: WATSON LABS
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 1974
- Application: ANDA084013
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 1974
- Application: ANDA084086
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 1974
- Application: ANDA084081
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 July 1974
- Application: ANDA084084
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 September 1974
- Application: ANDA083806
- Marketing authorisation holder: PHOENIX LABS NY
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 1975
- Application: ANDA084327
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 December 1975
- Application: ANDA084990
- Marketing authorisation holder: SOLVAY
- Local brand name: DEXONE 1.5
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 September 1976
- Application: ANDA083420
- Marketing authorisation holder: PVT FORM
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 1976
- Application: ANDA084754
- Marketing authorisation holder: KANCHAN HLTHCARE
- Local brand name: DEXAMETHASONE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 8 February 1977
- Application: ANDA085458
- Marketing authorisation holder: WATSON LABS
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 1977
- Application: ANDA085455
- Marketing authorisation holder: WATSON LABS
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 1977
- Application: ANDA085456
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 1978
- Application: ANDA084763
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 1978
- Application: ANDA084766
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 1978
- Application: ANDA084765
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 1978
- Application: ANDA084764
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 1978
- Application: ANDA084612
- Marketing authorisation holder: HIKMA
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 1983
- Application: ANDA088237
- Marketing authorisation holder: KEY THERAP
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 July 1983
- Application: ANDA088254
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Local brand name: DEXAMETHASONE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 1 September 1983
- Application: ANDA088248
- Marketing authorisation holder: HIKMA
- Local brand name: DEXAMETHASONE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 September 1983
- Application: ANDA088316
- Marketing authorisation holder: HIKMA
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 1983
- Application: ANDA084614
- Marketing authorisation holder: ROXANE
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 January 1984
- Application: ANDA088469
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DEXAMETHASONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 October 1984
- Application: ANDA062544
- Marketing authorisation holder: NOVARTIS
- Local brand name: DEXACIDIN
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 February 1985
- Application: ANDA062566
- Marketing authorisation holder: NOVARTIS
- Local brand name: DEXACIDIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA062721
- Marketing authorisation holder: ALCON PHARMS LTD
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 July 1989
- Application: ANDA062938
- Marketing authorisation holder: PADAGIS US
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 13 September 1995
- Application: ANDA064135
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: DEXASPORIN
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 15 August 2008
- Application: ANDA040700
- Marketing authorisation holder: BAUSCH
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 2011
- Application: ANDA091188
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: DEXAMETHASONE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 12 July 2011
- Application: ANDA090891
- Marketing authorisation holder: RISING
- Local brand name: DEXAMETHASONE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 17 July 2017
- Application: ANDA201270
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 2018
- Application: NDA208912
- Marketing authorisation holder: EYEPOINT PHARMS
- Local brand name: DEXYCU KIT
- Indication: SUSPENSION — INTRAOCULAR
- Status: approved
FDA — authorised 14 October 2021
- Application: ANDA215106
- Marketing authorisation holder: AMNEAL
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 August 2022
- Application: ANDA215604
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2022
- Application: ANDA216295
- Marketing authorisation holder: AMNEAL
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2023
- Application: ANDA217001
- Marketing authorisation holder: BIONPHARMA
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2023
- Application: ANDA217538
- Marketing authorisation holder: BIONPHARMA
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 2023
- Application: ANDA217696
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 2023
- Application: ANDA217695
- Marketing authorisation holder: APOTEX
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 2024
- Application: ANDA216282
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 2024
- Application: ANDA216283
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 2024
- Application: ANDA216284
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2024
- Application: ANDA218372
- Marketing authorisation holder: COREPHARMA
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088997
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: DEXAMETHASONE
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA088448
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: DEXAMETHASONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA013538
- Marketing authorisation holder: MERCK
- Local brand name: DECADERM
- Indication: GEL — TOPICAL
- Status: approved
FDA
- Application: ANDA087534
- Marketing authorisation holder: UPSHER SMITH
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087533
- Marketing authorisation holder: UPSHER SMITH
- Local brand name: DEXAMETHASONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084993
- Marketing authorisation holder: SOLVAY
- Local brand name: DEXONE 0.75
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084992
- Marketing authorisation holder: SOLVAY
- Local brand name: DEXONE 4
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084991
- Marketing authorisation holder: SOLVAY
- Local brand name: DEXONE 0.5
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA062411
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: DEXASPORIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
Frequently asked questions
Is Cohort A1 & A2: KTX-1001 approved in United States?
Yes. FDA authorised it on 21 December 1960; FDA authorised it on 20 April 1962; FDA authorised it on 20 October 1971.
Who is the marketing authorisation holder for Cohort A1 & A2: KTX-1001 in United States?
ASPEN GLOBAL INC holds the US marketing authorisation.