Viewing data from:

ERYTHROCIN

NDA

ERYTHROMYCIN LACTOBIONATE | N050609 | HOSPIRA INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

APITORIA PHARMA PRIVATE LTDERYTHROMYCIN LACTOBIONATE

DMF 340722019

GLAND PHARMA LTDERYTHROMYCIN LACTOBIONATE

DMF 344262019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDERYTHROMYCIN LACTOBIONATE

DMF 347502020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 500MG BASE/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 24, 1986

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 24, 1986