FDA Orange Book · active-ingredient family
Erythromycin
Erythromycin is approved as 10 brand and 64 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ERYGEL · NDA 050617
10
Brand (NDA)
64
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed rel pellets, gel, lotion, ointment, powder, solution, swab, tablet, tablet, coated particles, tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERYGELRLD | MYLAN | NDA 050617 | — | Oct 21, 1987 | |
| PCERLD×2 | AZURITY | NDA 050611 | — | Sep 09, 1986 | |
| ERYCETTERLD | JOHNSON AND JOHNSON | NDA 050594 | — | Feb 15, 1985 | |
| AKNE-MYCINRLD | BAUSCH | NDA 050584 | — | Jan 10, 1985 | |
| ERYCRLD | DR REDDYS LABS SA | NDA 050536 | AB | Approved Prior to Jan 1, 1982 | |
| STATICINRLD | WESTWOOD SQUIBB | NDA 050526 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN | PADDOCK LLC | NDA 050610 | — | Nov 07, 1986 | |
| ERYC SPRINKLES | HOSPIRA | NDA 050593 | — | Jul 22, 1985 | |
| ILOTYCIN | DISTA | NDA 050368 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN | LILLY | NDA 050532 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (64)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERYTHROMYCIN×2 | ABON PHARMS LLC | ANDA 219691 | AB | Sep 23, 2025 | |
| ERYTHROMYCIN×2 | ZYDUS PHARMS | ANDA 215440 | — | Aug 31, 2023 | |
| ERYTHROMYCIN×2 | ALEMBIC | ANDA 215661 | AB | Aug 24, 2023 | |
| ERYTHROMYCIN×2 | ZYDUS LIFESCIENCES | ANDA 212693 | AB | Mar 07, 2023 | |
| ERYTHROMYCIN×2 | ALKEM LABS LTD | ANDA 216066 | AB | Jul 13, 2022 | |
| ERYTHROMYCIN×3 | TORRENT | ANDA 211975 | AB | Jul 26, 2021 | |
| ERYTHROMYCIN×2 | CADILA PHARMS LTD | ANDA 213628 | AB | Jun 28, 2021 | |
| ERYTHROMYCIN×2 | TEVA PHARMS USA INC | ANDA 214549 | AB | Feb 11, 2021 | |
| ERYTHROMYCIN×2 | TORRENT | ANDA 212015 | AB | Jul 06, 2020 | |
| ERYTHROMYCIN×3 | AMNEAL PHARMS CO | ANDA 210954 | AB | Jul 02, 2019 | |
| ERYTHROMYCIN×2 | AMNEAL PHARMS CO | ANDA 209720 | — | Mar 09, 2018 | |
| ERYTHROMYCIN | ENCUBE | ANDA 208100 | — | Nov 20, 2017 | |
| ERYTHROMYCIN | ENCUBE | ANDA 208154 | — | Jul 19, 2017 | |
| ERYTHROMYCIN | EPIC PHARMA LLC | ANDA 090215 | AT | May 12, 2010 | |
| ERYTHROMYCIN | FOUGERA PHARMS | ANDA 065320 | — | Jul 25, 2006 | |
| E-GLADES | PHARMOBEDIENT | ANDA 065009 | — | Mar 18, 2002 | |
| ERYTHROMYCIN | FOUGERA PHARMS | ANDA 064184 | AT | Sep 30, 1997 | |
| ERYTHROMYCIN | FOUGERA PHARMS | ANDA 064187 | — | Sep 30, 1997 | |
| ERYTHROMYCIN | RENAISSANCE PHARMA | ANDA 064127 | — | Feb 14, 1997 | |
| ERYTHRO-STATIN | EPIC PHARMA LLC | ANDA 064101 | — | Oct 22, 1996 | |
| ERYTHROMYCIN | SENTISS | ANDA 064030 | AT | Jul 18, 1996 | |
| ERYTHROMYCIN | PADAGIS US | ANDA 064126 | AT | Jul 03, 1996 | |
| ERYTHROMYCIN | PHARMOBEDIENT | ANDA 064128 | — | Jul 03, 1996 | |
| ERYTHROMYCIN | BAUSCH AND LOMB INC | ANDA 064067 | AT | Jul 29, 1994 | |
| ERYTHROMYCIN | BAUSCH | ANDA 064039 | — | Jan 27, 1994 | |
| C-SOLVE-2 | IVAX SUB TEVA PHARMS | ANDA 062751 | — | Jul 30, 1993 | |
| ERYTHROMYCIN | PADAGIS US | ANDA 063211 | AT | Jan 29, 1993 | |
| EMGEL | ALTANA | ANDA 063107 | — | Aug 23, 1991 | |
| ERYTHROMYCIN | PADAGIS US | ANDA 063038 | AT | Jan 11, 1991 | |
| E-BASE | BARR | ANDA 063028 | — | May 15, 1990 | |
| E-BASE | BARR | ANDA 063086 | — | May 15, 1990 | |
| ERYTHROMYCIN | BARR | ANDA 063098 | — | May 04, 1989 | |
| E-BASE | BARR | ANDA 062999 | — | Nov 25, 1988 | |
| ERYTHROMYCIN | ALPHARMA US PHARMS | ANDA 062957 | — | Jul 21, 1988 | |
| ERYTHRA-DERM | MICRO LABS | ANDA 062687 | AT | Feb 05, 1988 | |
| ERYTHROMYCIN | PHARMOBEDIENT CNSLTG | ANDA 062825 | — | Oct 23, 1987 | |
| T-STAT | WESTWOOD SQUIBB | ANDA 062748 | — | Jul 23, 1987 | |
| ERYTHROMYCIN | CARNEGIE | ANDA 062746 | AB | Dec 22, 1986 | |
| ERYC 125 | PARKE DAVIS | ANDA 062648 | — | Oct 24, 1985 | |
| ERYC | PARKE DAVIS | ANDA 062618 | — | Sep 25, 1985 | |
| ERYC | PARKE DAVIS | ANDA 062546 | — | Jul 25, 1985 | |
| ERYTHROMYCIN | PHARMAFAIR | ANDA 062616 | — | Jul 25, 1985 | |
| ERYMAX | MERZ PHARMS | ANDA 062508 | — | Jul 11, 1985 | |
| E-SOLVE 2 | SYOSSET | ANDA 062467 | — | Jul 03, 1985 | |
| C-SOLVE-2 | FOUGERA PHARMS | ANDA 062468 | — | Jul 03, 1985 | |
| SANSAC | DOW PHARM | ANDA 062522 | — | Jan 24, 1985 | |
| ERYTHROMYCIN | PHARMAFAIR | ANDA 062485 | — | Jul 11, 1984 | |
| ERYTHROMYCIN | PHARMAFAIR | ANDA 062481 | — | Apr 05, 1984 | |
| ERYTHROMYCIN | PADAGIS US | ANDA 062447 | — | Sep 26, 1983 | |
| ERYTHROMYCIN | PHARMADERM | ANDA 062446 | — | Sep 26, 1983 | |
| T-STAT | WESTWOOD SQUIBB | ANDA 062436 | — | Mar 09, 1983 | |
| A/T/S | TARO | ANDA 062405 | — | Nov 18, 1982 | |
| ERYTHROMYCIN | ALPHARMA US PHARMS | ANDA 062328 | — | Apr 19, 1982 | |
| ERYTHROMYCIN | ALPHARMA US PHARMS | ANDA 062326 | — | Apr 19, 1982 | |
| ERYTHROMYCIN | ALPHARMA US PHARMS | ANDA 062327 | — | Apr 19, 1982 | |
| ERYTHROMYCIN | ALPHARMA US PHARMS | ANDA 062342 | — | Feb 25, 1982 | |
| ERYC | WARNER CHILCOTT LLC | ANDA 062338 | — | Approved Prior to Jan 1, 1982 | |
| ERYDERM | ARBOR PHARMS INC | ANDA 062290 | — | Approved Prior to Jan 1, 1982 | |
| E-MYCIN×2 | ARBOR PHARMS INC | ANDA 060272 | — | Approved Prior to Jan 1, 1982 | |
| ERY-TAB×3 | CARNEGIE | ANDA 062298 | AB | Approved Prior to Jan 1, 1982 | |
| ILOTYCIN | DISTA | ANDA 061910 | — | Approved Prior to Jan 1, 1982 | |
| R-P MYCIN | SOLVAY | ANDA 061659 | — | Approved Prior to Jan 1, 1982 | |
| ROBIMYCIN | ROBINS AH | ANDA 061633 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN×2 | CARNEGIE | ANDA 061621 | AB | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Erythromycin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
