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BUTAZOLIDIN

NDA

PHENYLBUTAZONE | N008319 | NOVARTIS PHARMACEUTICALS 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 Chain0 active DMFs5 inactive

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

AMSA ANONIMA MEDICINALI SINTETICI AND AFFINI SPAInactivePHENYLBUTAZONE

DMF 15481970

INQUIME INDS QUIMECA ESTENE SAInactivePHENYLBUTAZONE USP

DMF 17021970

RP SCHERER CORPInactivePHENYLBUTAZONE CAPSULES 100MG

DMF 19251972

NAPP CHEMICALS INCInactivePHENYLBUTAZONE

DMF 24231975

MEDIMPEX NORTHAMERICA INCInactivePHENYLBUTAZONE

DMF 25471975

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

Products (2)

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#008 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#009 — 100MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982