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BRETYLIUM TOSYLATE IN DEXTROSE 5%

NDA

BRETYLIUM TOSYLATE | N019005 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

3 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 - "Listing of Bretylium Tosylate 50 mg/mL Injection, Approved Dr... FDA-2011-P-0368 · 7 docket documents	Other	2011-06-20	Withdrawn	—

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 (3)

Sort:

#001 — 800MG/100ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 29, 1986

No patent or exclusivity listings for this strength.

#002 — 200MG/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 29, 1986

#003 — 400MG/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 29, 1986