FDA — authorised 2 September 1959
- Marketing authorisation holder: MERCK
- Status: approved
🇺🇸 Dexamethasone Sodium Phosphate in United States
FDA authorised Dexamethasone Sodium Phosphate on 2 September 1959
Marketing authorisations
FDA — authorised 17 September 1962
- Application: NDA013413
- Marketing authorisation holder: UCB INC
- Local brand name: DEXACORT
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 4 December 1964
- Application: NDA014694
- Marketing authorisation holder: ASPEN GLOBAL INC
- Local brand name: HEXADROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 1974
- Application: ANDA084170
- Marketing authorisation holder: SOLA BARNES HIND
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 February 1975
- Application: ANDA084173
- Marketing authorisation holder: SOLA BARNES HIND
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 15 July 1975
- Application: ANDA084282
- Marketing authorisation holder: HIKMA
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 May 1981
- Application: ANDA087065
- Marketing authorisation holder: LYPHOMED
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 July 1982
- Application: ANDA087668
- Marketing authorisation holder: WATSON LABS
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 1990
- Application: ANDA081125
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 1990
- Application: ANDA081126
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 July 1996
- Application: ANDA040069
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: SOLUTION/DROPS — OPHTHALMIC, OTIC
- Status: approved
FDA — authorised 22 April 2005
- Application: ANDA040572
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 August 2008
- Application: ANDA040802
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 August 2008
- Application: ANDA040803
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 2015
- Application: ANDA206781
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 April 2018
- Application: ANDA207442
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 June 2018
- Application: ANDA207521
- Marketing authorisation holder: SOMERSET
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2018
- Application: ANDA208690
- Marketing authorisation holder: AMNEAL
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2018
- Application: ANDA208689
- Marketing authorisation holder: AMNEAL
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 May 2019
- Application: ANDA211036
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 August 2021
- Application: ANDA215654
- Marketing authorisation holder: GLAND
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 July 2023
- Application: ANDA214890
- Marketing authorisation holder: GENEYORK PHARMS
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 August 2023
- Application: ANDA211451
- Marketing authorisation holder: HIKMA
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 March 2024
- Application: ANDA217797
- Marketing authorisation holder: MICRO LABS
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089280
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089281
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA062539
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA085606
- Marketing authorisation holder: WATSON LABS
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA084493
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088522
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA085641
- Marketing authorisation holder: WYETH AYERST
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089372
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089282
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: DEXAMETHASONE SODIUM PHOSPHATE
- Indication: Injectable — Injection
- Status: approved
Dexamethasone Sodium Phosphate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Dexamethasone Sodium Phosphate approved in United States?
Yes. FDA authorised it on 2 September 1959; FDA authorised it on 17 September 1962; FDA authorised it on 4 December 1964.
Who is the marketing authorisation holder for Dexamethasone Sodium Phosphate in United States?
MERCK holds the US marketing authorisation.