FDA Orange Book · active-ingredient family
Erythromycin lactobionate
Erythromycin lactobionate is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ERYTHROCIN · NDA 050609
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERYTHROCINRLD×2 | HOSPIRA | NDA 050609 | — | Sep 24, 1986 | |
| ERYTHROCIN×2 | HOSPIRA | NDA 050182 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERYTHROMYCIN LACTOBIONATE | GLAND | ANDA 216761 | AP | Nov 19, 2024 | |
| ERYTHROMYCIN LACTOBIONATE | NEXUS | ANDA 215290 | AP | Feb 14, 2022 | |
| ERYTHROMYCIN LACTOBIONATE | EXELA PHARMA | ANDA 211086 | — | Sep 17, 2020 | |
| ERYTHROMYCIN LACTOBIONATE×2 | TEVA PARENTERAL | ANDA 063253 | — | Jul 30, 1993 | |
| ERYTHROMYCIN LACTOBIONATE×2 | BAXTER HLTHCARE | ANDA 062993 | — | May 09, 1989 | |
| ERYTHROCIN×2 | ABBOTT | ANDA 062586 | — | Jan 04, 1988 | |
| ERYTHROMYCIN LACTOBIONATE×2 | ABRAXIS PHARM | ANDA 062604 | — | Nov 24, 1986 | |
| ERYTHROCIN×2 | HOSPIRA | ANDA 062638 | — | Oct 31, 1986 | |
| ERYTHROMYCIN×2 | ELKINS SINN | ANDA 062563 | — | Mar 28, 1985 |
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 lactobionate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
