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Generated: November 15, 2018

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Details for New Drug Application (NDA): 022004

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NDA 022004 describes OMNARIS, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OMNARIS profile page.

The generic ingredient in OMNARIS is ciclesonide. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ciclesonide profile page.
Summary for 022004
Tradename:OMNARIS
Applicant:Astrazeneca Pharms
Ingredient:ciclesonide
Patents:5
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022004
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMNARIS ciclesonide SPRAY, METERED;NASAL 022004 NDA Sunovion Pharmaceuticals Inc. 63402-701 63402-701-01 1 POUCH in 1 CARTON (63402-701-01) > 1 BOTTLE, SPRAY in 1 POUCH > 120 SPRAY in 1 BOTTLE, SPRAY
OMNARIS ciclesonide SPRAY, METERED;NASAL 022004 NDA Sunovion Pharmaceuticals Inc. 63402-701 63402-701-02 1 POUCH in 1 CARTON (63402-701-02) > 1 BOTTLE, SPRAY in 1 POUCH > 60 SPRAY in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.05MG/INH
Approval Date:Oct 20, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 21, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 21, 2019Product Flag?YSubstance Flag?Delist Request?

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