Viewing data from:

VAGISTAT-1

NDA

TIOCONAZOLE | N020676 | COMBE INC

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 Chain2 active DMFs1 inactive

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

ERREGIERRE SPATIOCONAZOLE

DMF 126131997

SOLARA ACTIVE PHARMA SCIENCES LTDTIOCONAZOLE

DMF 223992009

PFIZER LTDInactiveTIOCONAZOLE

DMF 48811983

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 10, 2009	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 6.5%

RLD

0 patents0 exclusivities▴

OINTMENT;VAGINAL | Approved: Feb 11, 1997

No patent or exclusivity listings for this strength.