FDA — authorised 24 June 1964
- Application: ANDA060359
- Marketing authorisation holder: AZURITY
- Local brand name: ERYTHROCIN STEARATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ERYTHROMYCIN STEARATE in United States
FDA authorised ERYTHROMYCIN STEARATE on 24 June 1964
Marketing authorisations
FDA — authorised 8 September 1972
- Application: ANDA061591
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ERYTHROMYCIN STEARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 January 1973
- Application: ANDA061505
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ERYTHROMYCIN STEARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 December 1974
- Application: ANDA061887
- Marketing authorisation holder: BRISTOL
- Local brand name: BRISTAMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 August 1977
- Application: ANDA062032
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: ERYPAR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 1980
- Application: ANDA061461
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ERYTHROMYCIN STEARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 1990
- Application: ANDA063179
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ERYTHROMYCIN STEARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA061304
- Marketing authorisation holder: BRISTOL
- Local brand name: BRISTAMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA061605
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: ETHRIL 500
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA062089
- Marketing authorisation holder: LEDERLE
- Local brand name: ERYTHROMYCIN STEARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA062121
- Marketing authorisation holder: WATSON LABS
- Local brand name: ERYTHROMYCIN STEARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA061675
- Marketing authorisation holder: WYETH AYERST
- Local brand name: WYAMYCIN S
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA062322
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: ERYPAR
- Indication: TABLET — ORAL
- Status: approved
ERYTHROMYCIN STEARATE 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 ERYTHROMYCIN STEARATE approved in United States?
Yes. FDA authorised it on 24 June 1964; FDA authorised it on 8 September 1972; FDA authorised it on 16 January 1973.
Who is the marketing authorisation holder for ERYTHROMYCIN STEARATE in United States?
AZURITY holds the US marketing authorisation.