Viewing data from:

AK-FLUOR 10%

NDA

FLUORESCEIN SODIUM | N022186 | LONG GROVE PHARMACEUTICALS LLC

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 Chain7 active DMFs1 inactive

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

DELMAR CHEMICALS INCFLUORESCEIN

DMF 187912005

ABBEY COLOR INCFLUORESCEIN USP

DMF 197772006

ICROM SRLFLUORESCEIN SODIUM

DMF 291442015

MACSEN DRUGSFLUORESCEIN SODIUM USP

DMF 389602023

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFLUORESCEIN SODIUM

DMF 393342023

ICROM SRLFLUORESCEIN SODIUM

DMF 393622024

APICORE LLCFLUORESCEIN SODIUM USP

DMF 409712024

EASTMAN KODAK COInactiveFLUORESCEIN

DMF 90941991

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Aug 8, 2008

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/2ML (EQ 250MG BASE/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Aug 8, 2008