Viewing data from:

GALZIN

NDA

ZINC ACETATE | N020458 | ETON PHARMACEUTICALS 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 Chain2 active DMFs

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

GLOBAL CALCIUM PRIVATE LTDZINC ACETATE USP

DMF 368722022

SICHUAN XIN KAI YUAN PHARMACEUTICAL CO LTDZINC ACETATE

DMF 428762025

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 26, 2024	SUPPL -9	View Letter (PDF)
Mar 14, 2002	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 25MG ZINC

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 28, 1997

No patent or exclusivity listings for this strength.

#002 — EQ 50MG ZINC

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 28, 1997