Viewing data from:

CORDRAN

NDA

FLURANDRENOLIDE | N016455 | ALMIRALL 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Scarguard Labs, LLC FDA-2009-P-0229 Scarguard Labs, LLC filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Psoriafilm (flurandrenolide, 4 micrograms per square centimeter in a topical collodion base formulation) is suitable for consideration in an a	Other	2009-05-27	Withdrawn	Scarguard Labs

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs2 inactive

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

FARMABIOS SPAFLURANDRENOLIDE

DMF 164922003

3M COFLURANDRENOLIDE DRUG-IN-ADHESIVE R-2813

DMF 387062024

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveFLURANDRENOLIDE

DMF 41071981

ANTIBIOTICOS SPAInactiveFLURANDRENOLIDE USP BULK FORM (NON-STERILE)

DMF 50631983

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

Products (1)

#001 — 0.004MG/SQ CM

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.