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DESONATE

NDA

DESONIDE | N021844 | LEO PHARMA AS

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVDESONIDE

DMF 44201982

FARMABIOS SPADESONIDE DRUG SUBSTANCE

DMF 195742006

AARTI PHARMALABS LTDDESONIDE

DMF 229632009

LINSON LTDInactiveDESONIDE

DMF 16711971

ASPEN OSS BVInactiveDESONIDE

DMF 39391980

ER SQUIBB AND SONS INCInactiveDESONIDE

DMF 40081980

NITA PHARMACEUTICAL LTDInactiveDESONIDE (PREDNACINOLONE 16,17 ACETONIDE

DMF 54761984

NEWCHEM SPAInactiveDESONIDE MICRONIZED

DMF 227492009

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 24, 2014	SUPPL -8	View Letter (PDF)
Jan 5, 2010	SUPPL -2	View Letter (PDF)
Oct 23, 2006	ORIG -1	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#001 — 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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▴

GEL;TOPICAL | Approved: Oct 20, 2006

No patent or exclusivity listings for this strength.