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HALOG

NDA

HALCINONIDE | N017824 | SUN PHARMACEUTICAL INDUSTRIES 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 Chain1 active DMF3 inactive

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

FARMABIOS SPAHALCINONIDE

DMF 183522005

BRISTOL MYERS SQUIBB COInactiveHALCINONIDE BULK

DMF 22031973

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveHALCINONIDE

DMF 74481988

FARMABOISInactiveHALCINONIDE

DMF 83351989

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 4, 2004	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.