FDA Orange Book · active-ingredient family
Erythromycin estolate
Erythromycin estolate: 1 brand, 12 generics; first approved Nov 18, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
12
Listed patents
0
Presentations
20
Brand (NDA) products
Originator applications
- LILLYNDA 050010—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 250MG BASE/5ML SUSPENSION ORAL Discontinued —
Generic (ANDA) products (12)
Abbreviated applications
- ERYTHROMYCIN ESTOLATECOSETTE PHARMS NCANDA 06216919902 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 250MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ESTOLATELIFE LABSANDA 0623621982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ESTOLATEALPHARMA US PHARMSANDA 0624091982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ESTOLATEALPHARMA US PHARMSANDA 0623531982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML SUSPENSION ORAL Discontinued — - ERYTHROMYCIN ESTOLATEBARRANDA 062162—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE CAPSULE ORAL Discontinued — EQ 250MG BASE CAPSULE ORAL Discontinued — - ERYTHROMYCIN ESTOLATEIVAX SUB TEVA PHARMSANDA 062237—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — - ERYTHROMYCIN ESTOLATEWATSON LABSANDA 062087—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued — - LILLYANDA 061897—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE CAPSULE ORAL Discontinued — EQ 250MG BASE CAPSULE ORAL Discontinued — - DISTAANDA 061893—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML FOR SUSPENSION ORAL Discontinued — - LILLYANDA 061894—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 250MG BASE/5ML SUSPENSION ORAL Discontinued — EQ 100MG BASE/ML SUSPENSION/DROPS ORAL Discontinued — - DISTAANDA 061895—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 250MG BASE TABLET, CHEWABLE ORAL Discontinued — - LILLYANDA 061896—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued —
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 5 mo ago
Most recent approval
36 yr 4 mo ago
Approvals span 1982–1990 across 13 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1292%
Erythromycin estolate: 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.
