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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 Kindeva 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. Thirty-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. Thirty-nine 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 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 AUTHORIZED GENERIC | Par Pharmaceutical Inc. | 0254-1007 | 0254-1007-52 | 1 CANISTER in 1 CARTON (0254-1007-52) > 200 AEROSOL, METERED in 1 CANISTER |
Paragraph IV (Patent) Challenges for 020503
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROVENTIL-HFA | AEROSOL, METERED;INHALATION | albuterol sulfate | 020503 | 2015-05-20 |
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: | AB1 | RLD: | 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 | Start Trial | Start Trial |
| Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | Start Trial | Start Trial |
| Kindeva | PROVENTIL-HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020503-001 | Aug 15, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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