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Last Updated: June 29, 2022

Details for New Drug Application (NDA): 020503


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NDA 020503 describes PROVENTIL-HFA, which is a drug marketed by Kindeva and is included in one NDA. It is available from nine suppliers. Additional details are available on the PROVENTIL-HFA profile page.

The generic ingredient in PROVENTIL-HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 020503
Tradename:PROVENTIL-HFA
Applicant:Kindeva
Ingredient:albuterol sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020503
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 020503
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503 NDA Merck Sharp & Dohme Corp. 0085-1132 0085-1132-04 1 CANISTER in 1 CARTON (0085-1132-04) > 200 AEROSOL, METERED in 1 CANISTER
PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503 NDA AUTHORIZED GENERIC Par Pharmaceutical Inc. 0254-1007 0254-1007-52 1 CANISTER in 1 CARTON (0254-1007-52) > 200 AEROSOL, METERED in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.09MG BASE/INH
Approval Date:Aug 15, 1996TE:AB1RLD:Yes

Expired US Patents for NDA 020503

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kindeva PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 See Plans and Pricing See Plans and Pricing
Kindeva PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 See Plans and Pricing See Plans and Pricing
Kindeva PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Medtronic
Express Scripts
Moodys
Merck

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