Viewing data from:

PROTOPAM CHLORIDE

NDA

PRALIDOXIME CHLORIDE | N014134 | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

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 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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 13, 2010	SUPPL -22	View Letter (PDF)
Sep 27, 2002	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM/VIAL

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.