FDA Orange Book · active-ingredient family
Erythromycin ethylsuccinate
Erythromycin ethylsuccinate: 2 brands, 20 generics; first approved Aug 12, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
20
Listed patents
0
Presentations
39
Brand (NDA) products
Originator applications
- E.E.S.RLDCARNEGIENDA 050207—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML GRANULE ORAL Rx AB EQ 400MG BASE/5ML GRANULE ORAL Rx AB EQ 200MG BASE/5ML GRANULE ORAL Rx AB - AZURITYNDA 050297—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 200MG BASE TABLET, CHEWABLE ORAL Discontinued —
Generic (ANDA) products (20)
Abbreviated applications
- ERYTHROMYCIN ETHYLSUCCINATECADILA PHARMS LTDANDA 21621220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML GRANULE ORAL Rx AB EQ 400MG BASE/5ML GRANULE ORAL Rx AB - ERYTHROMYCIN ETHYLSUCCINATEAMNEAL PHARMSANDA 21120420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML GRANULE ORAL Rx AB EQ 400MG BASE/5ML GRANULE ORAL Rx AB - ERYTHROMYCIN ETHYLSUCCINATEPH HEALTHANDA 21199120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML GRANULE ORAL Discontinued — EQ 400MG BASE/5ML GRANULE ORAL Discontinued — - ERYTHROMYCIN ETHYLSUCCINATEAUROBINDO PHARMA USAANDA 0628471988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Discontinued — - ERYTHROMYCIN ETHYLSUCCINATENASKAANDA 0626741987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ETHYLSUCCINATEPHARMAFAIRANDA 0625591985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ETHYLSUCCINATEPHARMAFAIRANDA 0625581985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ETHYLSUCCINATEANI PHARMSANDA 062055—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML GRANULE ORAL Rx AB EQ 400MG BASE/5ML GRANULE ORAL Rx AB EQ 200MG BASE/5ML GRANULE ORAL Rx AB - ROSS LABSANDA 062305—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML GRANULE ORAL Discontinued — EQ 100MG BASE/2.5ML SUSPENSION/DROPS ORAL Discontinued — - PHARMACIA AND UPJOHNANDA 062198—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 400MG BASE/5ML SUSPENSION ORAL Discontinued — - ARBOR PHARMS LLCANDA 061639—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 400MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ETHYLSUCCINATEALPHARMA US PHARMSANDA 062200—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 400MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ETHYLSUCCINATEDISTAANDA 062177—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 400MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ETHYLSUCCINATEPARKE DAVISANDA 062231—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 400MG BASE/5ML SUSPENSION ORAL Discontinued — - ARBOR PHARMS LLCANDA 062304—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 400MG BASE/5ML SUSPENSION ORAL Discontinued — - WYETH AYERSTANDA 062123—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 200MG BASE/5ML SUSPENSION ORAL Discontinued — - ROSS LABSANDA 062306—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE TABLET, CHEWABLE ORAL Discontinued — - CARNEGIEANDA 061905—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Discontinued — EQ 400MG BASE TABLET ORAL Rx BX - ERYTHROMYCIN ETHYLSUCCINATEBARRANDA 062256—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Discontinued — - ERYTHROMYCIN ETHYLSUCCINATERSCARNEGIEANDA 061904—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx BX
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 8 mo ago
Most recent approval
3 yr 9 mo ago
Approvals span 1982–2022 across 22 FDA applications.
Brand (NDA) 29%
Generic (ANDA) 2091%
Erythromycin ethylsuccinate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
