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EDECRIN

NDA

ETHACRYNATE SODIUM | N016093 | BAUSCH HEALTH AMERICAS INC

1 strength0 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 Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHEMWERTH INCETHACRYNATE SODIUM NON-STERILE, BULK DRUG

DMF 263382013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDETHACRYNATE SODIUM

DMF 308132016

SAI LIFE SCIENCES LTDInactiveETHACRYNATE SODIUM

DMF 316002017

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 11, 2005	SUPPL -44	View Letter (PDF)
Mar 2, 2004	SUPPL -43	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG BASE/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.