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Generated: November 14, 2018

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Details for New Drug Application (NDA): 207921

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NDA 207921 describes QVAR REDIHALER, which is a drug marketed by Norton Waterford and is included in one NDA. It is available from three suppliers. There are five patents protecting this drug. Additional details are available on the QVAR REDIHALER profile page.

The generic ingredient in QVAR REDIHALER is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.
Summary for 207921
Tradename:QVAR REDIHALER
Applicant:Norton Waterford
Ingredient:beclomethasone dipropionate
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 207921
Suppliers and Packaging for NDA: 207921
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QVAR REDIHALER beclomethasone dipropionate AEROSOL, METERED;INHALATION 207921 NDA A-S Medication Solutions 50090-3459 50090-3459-0 1 INHALER in 1 CARTON (50090-3459-0) > 1 CANISTER in 1 INHALER > 120 AEROSOL, METERED in 1 CANISTER
QVAR REDIHALER beclomethasone dipropionate AEROSOL, METERED;INHALATION 207921 NDA RPK Pharmaceuticals, Inc. 53002-2436 53002-2436-3 1 INHALER in 1 CARTON (53002-2436-3) > 1 AEROSOL, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.04MG/INH
Approval Date:Aug 3, 2017TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Aug 25, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 207921

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Norton Waterford QVAR REDIHALER beclomethasone dipropionate AEROSOL, METERED;INHALATION 207921-001 Aug 3, 2017 ➤ Sign Up ➤ Sign Up
Norton Waterford QVAR REDIHALER beclomethasone dipropionate AEROSOL, METERED;INHALATION 207921-002 Aug 3, 2017 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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