FDA — authorised 11 August 1941
- Marketing authorisation holder: LEDERLE
- Status: approved
🇺🇸 Sulfadiazine in United States
FDA authorised Sulfadiazine on 11 August 1941
Marketing authorisations
FDA — authorised 11 August 1941
- Application: NDA004054
- Marketing authorisation holder: LEDERLE
- Local brand name: SULFADIAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1941
- Application: NDA004122
- Marketing authorisation holder: LILLY
- Local brand name: SULFADIAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 July 1978
- Application: ANDA080084
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: SULFADIAZINE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Sulfadiazine for labeling indications. This approval was granted to Chartwell Molecular on November 14, 2024. The application number for this approval is ANDA080084.
FDA — authorised 15 September 1982
- Application: NDA017381
- Marketing authorisation holder: KING PHARMS LLC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 17 November 1986
- Application: NDA018810
- Marketing authorisation holder: THEPHARMANETWORK LLC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 March 1989
- Application: NDA018578
- Marketing authorisation holder: DR REDDYS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 29 July 1994
- Application: ANDA040091
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: SULFADIAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA004125
- Marketing authorisation holder: ABBVIE
- Local brand name: SULFADIAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA006317
- Marketing authorisation holder: LILLY
- Local brand name: SULFONAMIDES DUPLEX
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA080088
- Marketing authorisation holder: EVERYLIFE
- Local brand name: SULFADIAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080081
- Marketing authorisation holder: IMPAX LABS
- Local brand name: SULFADIAZINE
- Indication: TABLET — ORAL
- Status: approved
Sulfadiazine 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 Sulfadiazine approved in United States?
Yes. FDA authorised it on 11 August 1941; FDA authorised it on 11 August 1941; FDA authorised it on 26 August 1941.
Who is the marketing authorisation holder for Sulfadiazine in United States?
LEDERLE holds the US marketing authorisation.