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CORDRAN

NDA

FLURANDRENOLIDE | N013790 | INA PHARMACEUTICS 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 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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 29, 2011	SUPPL -21	View Letter (PDF)
Nov 25, 2003	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.