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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 Takeda Gmbh and is included in one NDA. It is available from two suppliers. There are six 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 NDA: 022004

Therapeutic Class:Respiratory Tract Agents

Suppliers and Packaging for NDA: 022004

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPRAY, METERED;NASAL 022004 NDA Physicians Total Care, Inc. 54868-6020 54868-6020-0 1 BOTTLE, GLASS in 1 POUCH (54868-6020-0) > 120 SPRAY in 1 BOTTLE, GLASS
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.05MG/INH
Approval Date:Oct 20, 2006TE:RLD:Yes
Patent:6,767,901Patent Expiration:Oct 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,939,559Patent Expiration:Apr 21, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:7,235,247Patent Expiration:Apr 21, 2019Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.