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PHISOHEX

NDA

HEXACHLOROPHENE | N006882 | SANOFI AVENTIS 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

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 DMFs6 inactive

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

NORTHEASTERN PHARMACEUTICALS AND CHEMICAL CO INCInactiveHEXACHLOROPHENE

DMF 15801970

GIVAUDAN CORPInactiveHEXACHLOROPHENE

DMF 15921970

CHEMSPEC CHEMICALS PVT LTDInactiveHEXACHLOROPHENE

DMF 55131984

VELSICOL CHEMICAL CORPInactiveHEXACHLOROPHENE

DMF 56391984

DC CHEMICAL CO LTDInactiveHEXACHLOROPHENE

DMF 64301986

THATCHER CHEMICAL COInactiveHEXACHLOROPHENE SOAP SOLUTION

DMF 93221991

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 8, 2003	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3%

0 patents0 exclusivities▴

EMULSION;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.