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Generated: November 12, 2018

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Details for New Drug Application (NDA): 020503

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NDA 020503 describes PROVENTIL-HFA, which is a drug marketed by 3m Drug Delivery and is included in one NDA. It is available from three 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-eight suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 020503
Tradename:PROVENTIL-HFA
Applicant:3m Drug Delivery
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 Merck Sharp & Dohme Corp. 0085-1132 0085-1132-01 1 CANISTER in 1 CARTON (0085-1132-01) > 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:BXRLD:Yes

Expired US Patents for NDA 020503

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 ➤ Sign Up ➤ Sign Up
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 ➤ Sign Up ➤ Sign Up
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 ➤ Sign Up ➤ Sign Up
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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