FDA — authorised 25 June 1964
- Application: NDA050182
- Marketing authorisation holder: HOSPIRA
- Local brand name: ERYTHROCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 E-Mycin in United States
FDA authorised E-Mycin on 25 June 1964
Marketing authorisations
FDA — authorised 27 February 1975
- Application: ANDA061910
- Marketing authorisation holder: DISTA
- Local brand name: ILOTYCIN
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 3 June 1980
- Application: NDA050532
- Marketing authorisation holder: LILLY
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 3 June 1980
- Application: NDA050526
- Marketing authorisation holder: WESTWOOD SQUIBB
- Local brand name: STATICIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 8 October 1980
- Application: ANDA062290
- Marketing authorisation holder: ARBOR PHARMS INC
- Local brand name: ERYDERM
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 26 January 1981
- Application: NDA050536
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: ERYC
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 23 June 1981
- Application: ANDA060272
- Marketing authorisation holder: ARBOR PHARMS INC
- Local brand name: E-MYCIN
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 29 March 1982
- Application: ANDA062298
- Marketing authorisation holder: CARNEGIE
- Local brand name: ERY-TAB
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 January 1985
- Application: ANDA062522
- Marketing authorisation holder: DOW PHARM
- Local brand name: SANSAC
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 15 February 1985
- Application: NDA050594
- Marketing authorisation holder: JOHNSON AND JOHNSON
- Local brand name: ERYCETTE
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 28 March 1985
- Application: ANDA062563
- Marketing authorisation holder: ELKINS SINN
- Local brand name: ERYTHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 July 1985
- Application: ANDA062467
- Marketing authorisation holder: SYOSSET
- Local brand name: E-SOLVE 2
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 3 July 1985
- Application: ANDA062468
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: C-SOLVE-2
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 11 July 1985
- Application: ANDA062508
- Marketing authorisation holder: MERZ PHARMS
- Local brand name: ERYMAX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 22 July 1985
- Application: NDA050593
- Marketing authorisation holder: HOSPIRA
- Local brand name: ERYC SPRINKLES
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 25 July 1985
- Application: ANDA062616
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 9 September 1986
- Application: NDA050611
- Marketing authorisation holder: AZURITY
- Local brand name: PCE
- Indication: TABLET, COATED PARTICLES — ORAL
- Status: approved
FDA — authorised 24 September 1986
- Application: NDA050609
- Marketing authorisation holder: HOSPIRA
- Local brand name: ERYTHROCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 October 1986
- Application: ANDA062638
- Marketing authorisation holder: HOSPIRA
- Local brand name: ERYTHROCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 October 1987
- Application: NDA050617
- Marketing authorisation holder: MYLAN
- Local brand name: ERYGEL
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 4 January 1988
- Application: ANDA062586
- Marketing authorisation holder: ABBOTT
- Local brand name: ERYTHROCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 November 1988
- Application: ANDA062999
- Marketing authorisation holder: BARR
- Local brand name: E-BASE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 4 May 1989
- Application: ANDA063098
- Marketing authorisation holder: BARR
- Local brand name: ERYTHROMYCIN
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 15 May 1990
- Application: ANDA063086
- Marketing authorisation holder: BARR
- Local brand name: E-BASE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 15 May 1990
- Application: ANDA063028
- Marketing authorisation holder: BARR
- Local brand name: E-BASE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 11 January 1991
- Application: ANDA063038
- Marketing authorisation holder: PADAGIS US
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 23 August 1991
- Application: ANDA063107
- Marketing authorisation holder: ALTANA
- Local brand name: EMGEL
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 3 July 1996
- Application: ANDA064128
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ERYTHROMYCIN
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 3 July 1996
- Application: ANDA064126
- Marketing authorisation holder: PADAGIS US
- Local brand name: ERYTHROMYCIN
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 14 February 1997
- Application: ANDA064127
- Marketing authorisation holder: RENAISSANCE PHARMA
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 30 September 1997
- Application: ANDA064184
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 30 September 1997
- Application: ANDA064187
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 20 April 1998
- Application: ANDA061621
- Marketing authorisation holder: CARNEGIE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 March 2002
- Application: ANDA065009
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: E-GLADES
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 25 July 2006
- Application: ANDA065320
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 12 May 2010
- Application: ANDA090215
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: ERYTHROMYCIN
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 1 September 2010
- Application: ANDA064030
- Marketing authorisation holder: SENTISS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 9 March 2018
- Application: ANDA209720
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 November 2019
- Application: ANDA211204
- Marketing authorisation holder: AMNEAL PHARMS
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA212015
- Marketing authorisation holder: TORRENT
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA214549
- Marketing authorisation holder: TEVA PHARMS USA INC
- Status: approved
FDA — authorised 28 June 2021
- Application: ANDA213628
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2021
- Application: ANDA211975
- Marketing authorisation holder: TORRENT
- Local brand name: ERYTHROMYCIN
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 13 July 2022
- Application: ANDA216066
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2022
- Application: ANDA216212
- Marketing authorisation holder: CADILA PHARMS LTD
- Status: approved
FDA — authorised 24 August 2023
- Application: ANDA215661
- Marketing authorisation holder: ALEMBIC
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA062546
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: ERYC
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA
- Application: ANDA062618
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: ERYC
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA
- Application: ANDA062485
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: ANDA062481
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: ERYTHROMYCIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA062648
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: ERYC 125
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA
- Application: NDA050610
- Marketing authorisation holder: PADDOCK LLC
- Local brand name: ERYTHROMYCIN
- Indication: POWDER — FOR RX COMPOUNDING
- Status: approved
FDA
- Application: ANDA062957
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
E-Mycin 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 E-Mycin approved in United States?
Yes. FDA authorised it on 25 June 1964; FDA authorised it on 27 February 1975; FDA authorised it on 3 June 1980.
Who is the marketing authorisation holder for E-Mycin in United States?
HOSPIRA holds the US marketing authorisation.