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Details for New Drug Application (NDA): 020503
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-nine suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
The generic ingredient in PROVENTIL-HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-nine 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 Action | Adrenergic 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: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | EQ 0.09MG BASE/INH | ||||
| Approval Date: | Aug 15, 1996 | TE: | BX | RLD: | Yes | ||||
Expired US Patents for NDA 020503
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