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Details for New Drug Application (NDA): 202129

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NDA 202129 describes ZETONNA, which is a drug marketed by Takeda Gmbh and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ZETONNA profile page.

The generic ingredient in ZETONNA is ciclesonide. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ciclesonide profile page.

Summary for NDA: 202129

Tradename:
ZETONNA
Applicant:
Takeda Gmbh
Ingredient:
ciclesonide
Patents:6
Therapeutic Class:Respiratory Tract Agents

Suppliers and Packaging for NDA: 202129

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL 202129 NDA Sunovion Pharmaceuticals Inc. 63402-737 63402-737-30 1 CANISTER in 1 CARTON (63402-737-30) > 30 AEROSOL, METERED in 1 CANISTER
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL 202129 NDA Sunovion Pharmaceuticals Inc. 63402-737 63402-737-60 1 CANISTER in 1 CARTON (63402-737-60) > 60 AEROSOL, METERED in 1 CANISTER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;NASALStrength0.037MG/INH
Approval Date:Jan 20, 2012TE:RLD:Yes
Patent:5,775,321Patent Expiration:Jul 7, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:6,006,745Patent Expiration:Dec 28, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,120,752Patent Expiration:May 13, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 202129

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 20125,605,674► subscribe
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 20126,036,942► subscribe
Takeda Gmbh
ZETONNA
ciclesonide
AEROSOL, METERED;NASAL202129-001Jan 20, 20125,775,321► subscribe
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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.

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