Viewing data from:

BRETYLIUM TOSYLATE

NDA

BRETYLIUM TOSYLATE | N019030 | HOSPIRA WORLDWIDE, 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
Academic Pharmaceuticals, Inc. - Citizen Petition FDA-2011-P-0578 · 4 docket documents Academic Pharmaceuticals, Inc. filed this citizen petition on July 27, 2011, requesting that the FDA determine whether Bretylium Tosylate Injection 50 mg/mL (NDA #019030) was discontinued due to safety or effectiveness issues and, if not, to relist the drug in the Orange Book to enable reintroductio	Other	2011-08-12	Open	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF2 inactive

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

TOPCHEM PHARMACEUTICALS LTDBRETYLIUM TOSYLATE

DMF 259372012

GANES CHEMICALS INC PENNSVILLE DIVInactiveBRETYLIUM TOSYLATE

DMF 27291976

DELMAR CHEMICALS INCInactiveBRETYLIUM TOSYLATE, BULK FORM

DMF 33611978

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

Products (1)

#001 — 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 29, 1986

No patent or exclusivity listings for this strength.