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Details for New Drug Application (NDA): 202813

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NDA 202813 describes QNASL, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the QNASL profile page.

The generic ingredient in QNASL 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: 202813

Tradename:
QNASL
Applicant:
Teva Branded Pharm
Ingredient:
beclomethasone dipropionate
Patents:2
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202813

Suppliers and Packaging for NDA: 202813

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QNASL
beclomethasone dipropionate
AEROSOL, METERED;NASAL 202813 NDA Teva Respiratory, LLC 59310-206 59310-206-06 1 INHALER in 1 CARTON (59310-206-06) > 60 AEROSOL, METERED in 1 INHALER
QNASL
beclomethasone dipropionate
AEROSOL, METERED;NASAL 202813 NDA Teva Respiratory, LLC 59310-206 59310-206-08 1 INHALER in 1 CARTON (59310-206-08) > 60 AEROSOL, METERED in 1 INHALER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;NASALStrength0.08MG/ACTUATION
Approval Date:Mar 23, 2012TE:RLD:Yes
Patent:5,776,432Patent Expiration:Jul 7, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:7,780,038Patent Expiration:Jan 24, 2027Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;NASALStrength0.04MG/ACTUATION
Approval Date:Dec 17, 2014TE:RLD:No
Patent:5,776,432Patent Expiration:Jul 7, 2015Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 202813

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm
QNASL
beclomethasone dipropionate
AEROSOL, METERED;NASAL202813-002Dec 17, 20145,776,432► subscribe
Teva Branded Pharm
QNASL
beclomethasone dipropionate
AEROSOL, METERED;NASAL202813-001Mar 23, 20125,605,674► subscribe
Teva Branded Pharm
QNASL
beclomethasone dipropionate
AEROSOL, METERED;NASAL202813-001Mar 23, 20125,776,432► subscribe
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