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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 and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug. Additional details are available on the PROVENTIL-HFA profile page.

The generic ingredient in PROVENTIL-HFA is albuterol sulfate. There are thirty-six 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 NDA: 020503

Tradename:
PROVENTIL-HFA
Applicant:
3m
Ingredient:
albuterol sulfate
Patents:2
Therapeutic Class:Respiratory Tract Agents
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 0085-1132-01 1 CANISTER in 1 CARTON (0085-1132-01) > 200 AEROSOL, METERED in 1 CANISTER
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION 020503 NDA Merck Sharp & Dohme Corp. 0085-1132 0085-1132-02 1 CANISTER in 1 CARTON (0085-1132-02) > 100 AEROSOL, METERED in 1 CANISTER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.09MG BASE/INH
Approval Date:Aug 15, 1996TE:BXRLD:Yes
Patent:5,775,321Patent Expiration:Jul 7, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:6,006,745Patent Expiration:Dec 28, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020503

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 19966,352,684► subscribe
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 19965,225,183► subscribe
3m
PROVENTIL-HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020503-001Aug 15, 19965,695,743► subscribe
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