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Details for New Drug Application (NDA): 020911

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NDA 020911 describes QVAR 80, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from four suppliers. There are three patents protecting this drug. Additional details are available on the QVAR 80 profile page.

The generic ingredient in QVAR 80 is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.

Summary for NDA: 020911

Tradename:
QVAR 40
Applicant:
Teva Branded Pharm
Ingredient:
beclomethasone dipropionate
Patents:3
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020911

Suppliers and Packaging for NDA: 020911

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QVAR 40
beclomethasone dipropionate
AEROSOL, METERED;INHALATION 020911 NDA STAT RX USA LLC 16590-860 16590-860-71 1 CANISTER in 1 BOX (16590-860-71) > 100 AEROSOL, METERED in 1 CANISTER
QVAR 40
beclomethasone dipropionate
AEROSOL, METERED;INHALATION 020911 NDA A-S Medication Solutions 50090-1342 50090-1342-0 1 CANISTER in 1 BOX (50090-1342-0) > 120 AEROSOL, METERED in 1 CANISTER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.08MG/INH
Approval Date:Sep 15, 2000TE:RLD:Yes
Patent:6,446,627Patent Expiration:Dec 18, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:9,463,289Patent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:5,776,432Patent Expiration:Jul 7, 2015Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ASTHMA

Expired Orange Book Patents for NDA: 020911

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm
QVAR 80
beclomethasone dipropionate
AEROSOL, METERED;INHALATION020911-001Sep 15, 20005,766,573► subscribe
Teva Branded Pharm
QVAR 80
beclomethasone dipropionate
AEROSOL, METERED;INHALATION020911-001Sep 15, 20005,776,432► subscribe
Teva Branded Pharm
QVAR 40
beclomethasone dipropionate
AEROSOL, METERED;INHALATION020911-002Sep 15, 20005,605,674► subscribe
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