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FEMSTAT

NDA

BUTOCONAZOLE NITRATE | N019359 | ROCHE PALO ALTO LLC

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 Chain1 active DMF5 inactive

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

DERIVADOS QUIMICOS SAUBUTOCONAZOLE NITRATE

DMF 189812005

ROCHE PALO ALTO LLCInactiveBUTOCONAZOLE NITRATE

DMF 33511978

KV PHARMACEUTICAL COInactiveBUTOCONAZOLE NITRATE 2% VAGINAL CREAM

DMF 95851992

QUIMICA SINTETICA SAInactiveBUTOCONAZOLE NITRATE

DMF 131061998

GEDEON RICHTER PLCInactiveBUTOCONAZOLE NITRATE

DMF 159292002

HONEYWELL IROPHARM PLCInactiveBUTOCONAZOLE

DMF 179442004

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

Products (1)

#001 — 100MG

0 patents0 exclusivities▴

SUPPOSITORY;VAGINAL | Approved: Nov 25, 1985

No patent or exclusivity listings for this strength.