FDA — authorised 29 June 1964
- Application: NDA050368
- Marketing authorisation holder: DISTA
- Local brand name: ILOTYCIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
🇺🇸 Cephalosporins and Macrolide Antibiotics in United States
FDA authorised Cephalosporins and Macrolide Antibiotics on 29 June 1964
Marketing authorisations
FDA — authorised 11 July 1972
- Application: ANDA061621
- Marketing authorisation holder: CARNEGIE
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
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: NDA050526
- Marketing authorisation holder: WESTWOOD SQUIBB
- Local brand name: STATICIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 3 June 1980
- Application: NDA050532
- Marketing authorisation holder: LILLY
- Local brand name: ERYTHROMYCIN
- 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 22 May 1981
- Application: ANDA062338
- Marketing authorisation holder: WARNER CHILCOTT LLC
- Local brand name: ERYC
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 19 April 1982
- Application: ANDA062326
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 19 April 1982
- Application: ANDA062328
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 10 January 1985
- Application: NDA050584
- Marketing authorisation holder: BAUSCH
- Local brand name: AKNE-MYCIN
- Indication: OINTMENT — TOPICAL
- 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: ANDA062468
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: C-SOLVE-2
- Indication: SOLUTION — TOPICAL
- 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 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 22 December 1986
- Application: ANDA062746
- Marketing authorisation holder: CARNEGIE
- Local brand name: ERYTHROMYCIN
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 23 July 1987
- Application: ANDA062748
- Marketing authorisation holder: WESTWOOD SQUIBB
- Local brand name: T-STAT
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 21 October 1987
- Application: NDA050617
- Marketing authorisation holder: MYLAN
- Local brand name: ERYGEL
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 5 February 1988
- Application: ANDA062687
- Marketing authorisation holder: MICRO LABS
- Local brand name: ERYTHRA-DERM
- Indication: SOLUTION — TOPICAL
- 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: ANDA063028
- Marketing authorisation holder: BARR
- Local brand name: E-BASE
- Indication: TABLET, DELAYED RELEASE — 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 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 29 January 1993
- Application: ANDA063211
- Marketing authorisation holder: PADAGIS US
- Local brand name: ERYTHROMYCIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 30 July 1993
- Application: ANDA062751
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: C-SOLVE-2
- Indication: SWAB — TOPICAL
- Status: approved
FDA — authorised 27 January 1994
- Application: ANDA064039
- Marketing authorisation holder: BAUSCH
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — 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 18 July 1996
- Application: ANDA064030
- Marketing authorisation holder: SENTISS
- Local brand name: ERYTHROMYCIN
- Indication: OINTMENT — OPHTHALMIC
- 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 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 20 November 2017
- Application: ANDA208100
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- 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 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
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- 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 24 August 2023
- Application: ANDA215661
- Marketing authorisation holder: ALEMBIC
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 2023
- Application: ANDA215440
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 2025
- Application: ANDA219691
- Marketing authorisation holder: ABON PHARMS LLC
- Local brand name: ERYTHROMYCIN
- Indication: TABLET — ORAL
- 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: ANDA062327
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: ANDA062957
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: ANDA062485
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: ANDA062342
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: ERYTHROMYCIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: ANDA061633
- Marketing authorisation holder: ROBINS AH
- Local brand name: ROBIMYCIN
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: NDA050610
- Marketing authorisation holder: PADDOCK LLC
- Local brand name: ERYTHROMYCIN
- Indication: POWDER — FOR RX COMPOUNDING
- Status: approved
FDA
- Application: ANDA062618
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: ERYC
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA
- Application: ANDA061659
- Marketing authorisation holder: SOLVAY
- Local brand name: R-P MYCIN
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA062546
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: ERYC
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
Frequently asked questions
Is Cephalosporins and Macrolide Antibiotics approved in United States?
Yes. FDA authorised it on 29 June 1964; FDA authorised it on 11 July 1972; FDA authorised it on 27 February 1975.
Who is the marketing authorisation holder for Cephalosporins and Macrolide Antibiotics in United States?
DISTA holds the US marketing authorisation.