FDA — authorised 21 July 1946
- Application: NDA005963
- Marketing authorisation holder: SCHERING
- Local brand name: SODIUM SULAMYD
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
🇺🇸 SULFACETAMIDE SODIUM in United States
FDA authorised SULFACETAMIDE SODIUM on 21 July 1946 · 379 US adverse-event reports
Marketing authorisations
FDA — authorised 29 September 1970
- Application: ANDA080024
- Marketing authorisation holder: OPTOPICS
- Local brand name: SULFACEL-15
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 May 1971
- Application: ANDA080020
- Marketing authorisation holder: ALCON
- Local brand name: ISOPTO CETAMIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 May 1971
- Application: ANDA080028
- Marketing authorisation holder: ALLERGAN
- Local brand name: BLEPH-10
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 December 1971
- Application: ANDA080029
- Marketing authorisation holder: PADAGIS US
- Local brand name: SULFACETAMIDE SODIUM
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 24 August 1972
- Application: ANDA080660
- Marketing authorisation holder: MIZA PHARMS USA
- Local brand name: OCUSULF-30
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 27 September 1972
- Application: ANDA080021
- Marketing authorisation holder: ALCON
- Local brand name: CETAMIDE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 1 November 1974
- Application: ANDA084145
- Marketing authorisation holder: SOLA BARNES HIND
- Local brand name: SODIUM SULFACETAMIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 1 November 1974
- Application: ANDA084146
- Marketing authorisation holder: SOLA BARNES HIND
- Local brand name: SODIUM SULFACETAMIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 November 1974
- Application: ANDA084143
- Marketing authorisation holder: SOLA BARNES HIND
- Local brand name: SODIUM SULFACETAMIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 December 1974
- Application: ANDA084147
- Marketing authorisation holder: SOLA BARNES HIND
- Local brand name: SODIUM SULFACETAMIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 7 January 1975
- Application: ANDA084015
- Marketing authorisation holder: ALLERGAN
- Local brand name: BLEPH-10
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 22 December 1982
- Application: ANDA088000
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: SULFAIR 10
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 5 May 1987
- Application: ANDA089068
- Marketing authorisation holder: ALCON PHARMS LTD
- Local brand name: SULFACETAMIDE SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 December 1994
- Application: ANDA040066
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: SULFACETAMIDE SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 October 1995
- Application: ANDA089047
- Marketing authorisation holder: NOVARTIS
- Local brand name: SULF-15
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 May 1999
- Application: ANDA040216
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: SULFACETAMIDE SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 May 1999
- Application: ANDA040215
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: SULFACETAMIDE SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 23 March 2009
- Application: ANDA078649
- Marketing authorisation holder: PADAGIS US
- Local brand name: SULFACETAMIDE SODIUM
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 20 May 2009
- Application: ANDA078668
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: SULFACETAMIDE SODIUM
- Indication: LOTION — TOPICAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA080025
- Marketing authorisation holder: NOVARTIS
- Local brand name: SULF-10
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA087949
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: SULFAIR 10
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA083021
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: SODIUM SULFACETAMIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA088385
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: SULFAIR FORTE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA088947
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: SULFACETAMIDE SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 379
Most-reported reactions
- Drug Hypersensitivity — 77 reports (20.32%)
- Drug Ineffective — 47 reports (12.4%)
- Headache — 40 reports (10.55%)
- Dyspnoea — 38 reports (10.03%)
- Nausea — 34 reports (8.97%)
- Fatigue — 31 reports (8.18%)
- Off Label Use — 31 reports (8.18%)
- Rash — 29 reports (7.65%)
- Weight Decreased — 27 reports (7.12%)
- Diarrhoea — 25 reports (6.6%)
SULFACETAMIDE SODIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SULFACETAMIDE SODIUM approved in United States?
Yes. FDA authorised it on 21 July 1946; FDA authorised it on 29 September 1970; FDA authorised it on 5 May 1971.
Who is the marketing authorisation holder for SULFACETAMIDE SODIUM in United States?
SCHERING holds the US marketing authorisation.