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BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA

BRETYLIUM TOSYLATE | N019837 | BAXTER HEALTHCARE CORP

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 Chain1 active DMF1 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

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

Products (2)

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#001 — 400MG/100ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 12, 1989

No patent or exclusivity listings for this strength.

#002 — 200MG/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 12, 1989