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PRALIDOXIME CHLORIDE (AUTOINJECTOR)

NDA

PRALIDOXIME CHLORIDE | N018986 | MERIDIAN MEDICAL TECHNOLOGIES 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Premier Research International LLC FDA-2026-P-3632 · 5 docket documents Premier Research International, LLC filed this citizen petition requesting that the FDA determine that Pralidoxime Chloride (Autoinjector) 600 mg/2 mL intramuscular solution (NDA 018986) from Meridian Medical Technologies Inc. was not discontinued or withdrawn due to safety or efficacy reasons, to s	505(q)	2026-04-02	Open	Premier Research International LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs1 inactive

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

CURIA NEW YORK INCPRALIDOXIME CHLORIDE USP

DMF 142081999

DISHMAN CARBOGEN AMCIS LTDPRALIDOXIME CHLORIDE

DMF 213072008

WAVELENGTH ENTERPRISES LTDPRALIDOXIME CHLORIDE

DMF 366162022

PHARM ECO LABORATORIES INCInactivePRALIDOXIME CHLORIDE USP

DMF 70651987

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

Products (1)

#001 — 600MG/2ML (300MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: Apr 26, 1983

No patent or exclusivity listings for this strength.