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Cantor Fitzgerald
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Generated: April 22, 2019

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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 Astrazeneca Pharms and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the ciclesonide profile page.
Summary for 202129
Tradename:ZETONNA
Applicant:Astrazeneca Pharms
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 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;NASALStrength0.037MG/INH
Approval Date:Jan 20, 2012TE:RLD:Yes
Patent:➤ Sign UpPatent 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
Astrazeneca Pharms ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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