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Not in the current Orange Book— This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

MENTAX

NDANot in Orange Book

BUTENAFINE HYDROCHLORIDE | N020663 | MYLAN BERTEK

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 Chain2 active DMFs

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

ERREGIERRE SPABUTENAFINE HYDROCHLORIDE

DMF 187072005

TARO PHARMACEUTICAL INDUSTRIES LTDBUTENAFINE HYDROCHLORIDE

DMF 195512006

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

Products (1)

#001 — 1%

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CREAM; TOPICAL | Approved: Dec. 31, 1996

No patent or exclusivity listings for this strength.