FDA Orange Book · active-ingredient family
Erythromycin lactobionate
Erythromycin lactobionate: 2 brands, 9 generics; first approved Mar 28, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
9
Listed patents
0
Presentations
19
Brand (NDA) products
Originator applications
- ERYTHROCINRLDHOSPIRANDA 05060919862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRANDA 050182—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- ERYTHROMYCIN LACTOBIONATEGLANDANDA 2167612024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - ERYTHROMYCIN LACTOBIONATENEXUSANDA 2152902022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - ERYTHROMYCIN LACTOBIONATEEXELA PHARMAANDA 2110862020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ERYTHROMYCIN LACTOBIONATETEVA PARENTERALANDA 06325319932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ERYTHROMYCIN LACTOBIONATEBAXTER HLTHCAREANDA 06299319892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 06258619882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ERYTHROMYCIN LACTOBIONATEABRAXIS PHARMANDA 06260419862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 06263819862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ELKINS SINNANDA 06256319852 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION 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
42 yr ago
Most recent approval
1 yr 9 mo ago
Approvals span 1985–2024 across 11 FDA applications.
Brand (NDA) 218%
Generic (ANDA) 982%
Erythromycin lactobionate: 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.
