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Last Updated: July 10, 2020

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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 Covis Pharma Bv and is included in one NDA. It is available from one supplier. There is one patent 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. One supplier is listed for this compound. Additional details are available on the ciclesonide profile page.
Summary for 202129
Tradename:ZETONNA
Applicant:Covis Pharma Bv
Ingredient:ciclesonide
Patents:1
Formulation / Manufacturing:see details
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 Covis Pharma 70515-737 70515-737-60 1 CANISTER in 1 CARTON (70515-737-60) > 60 AEROSOL, METERED in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;NASALStrength0.037MG/INH
Approval Date:Jan 20, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 1, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR TREATING A RESPIRATORY DISEASE IN A CHILD

Expired US Patents for NDA 202129

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis Pharma Bv ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012   Start Trial   Start Trial
Covis Pharma Bv ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012   Start Trial   Start Trial
Covis Pharma Bv ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012   Start Trial   Start Trial
Covis Pharma Bv ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012   Start Trial   Start Trial
Covis Pharma Bv ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012   Start Trial   Start Trial
Covis Pharma Bv ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012   Start Trial   Start Trial
Covis Pharma Bv ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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