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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

OMNARIS

NDANot in Orange Book

CICLESONIDE | N022124 | NYCOMED US INC

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 Chain5 active DMFs2 inactive

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

DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMTECHNIKCICLESONIDE

DMF 166062003

STERLING SPACICLESONIDE

DMF 225872009

AARTI PHARMALABS LTDCICLESONIDE

DMF 236502010

CORAL DRUGS PVT LTDCICLESONIDE

DMF 382832023

NEWCHEM SPACICLESONIDE

DMF 422892025

MICRONISIERUNGS KONTOR OBERROT GMBHInactiveCICLESONIDE, MICRONIZED (ITEM NO. 37)

DMF 190282005

ALP PHARM BEIJING CO LTDInactiveCICLESONIDE

DMF 242552010

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 26, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MCG

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SPRAY; NASAL | Approved: Nov. 21, 2007

No patent or exclusivity listings for this strength.