Orange Book product · Brand (NDA)
ERYTHROCIN
ERYTHROMYCIN LACTOBIONATE
At a glance
Sep 24, 1986
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 24, 1986
40 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ERYTHROMYCIN LACTOBIONATE
Strength
EQ 500MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050609
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —ERYTHROCINBrand (NDA)
NDA 050182 · HOSPIRA
- 2024ERYTHROMYCIN LACTOBIONATEGeneric (ANDA)
ANDA 216761 · GLAND
- 2022ERYTHROMYCIN LACTOBIONATEGeneric (ANDA)
ANDA 215290 · NEXUS
- 2020ERYTHROMYCIN LACTOBIONATEGeneric (ANDA)
ANDA 211086 · EXELA PHARMA
- 1993ERYTHROMYCIN LACTOBIONATEGeneric (ANDA)
ANDA 063253 · TEVA PARENTERAL
- 1989ERYTHROMYCIN LACTOBIONATEGeneric (ANDA)
ANDA 062993 · BAXTER HLTHCARE
- 1988ERYTHROCINGeneric (ANDA)
ANDA 062586 · ABBOTT
- 1986ERYTHROMYCIN LACTOBIONATEGeneric (ANDA)
ANDA 062604 · ABRAXIS PHARM
- 1986ERYTHROCINGeneric (ANDA)
ANDA 062638 · HOSPIRA
- 1985ERYTHROMYCINGeneric (ANDA)
ANDA 062563 · ELKINS SINN
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.
