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BUTOCONAZOLE NITRATE

NDA

BUTOCONAZOLE NITRATE | N019881 | PADAGIS US 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 6, 2003	SUPPL -9	View Letter (PDF)
May 30, 2003	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2%

0 patents0 exclusivities▴

CREAM;VAGINAL | Approved: Feb 7, 1997

No patent or exclusivity listings for this strength.