Details for New Drug Application (NDA): 020983
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NDA 020983 describes VENTOLIN HFA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from ten suppliers. Additional details are available on the VENTOLIN HFA profile page.
The generic ingredient in VENTOLIN HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
The generic ingredient in VENTOLIN HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 020983
| Tradename: | VENTOLIN HFA |
| Applicant: | Glaxosmithkline |
| Ingredient: | albuterol sulfate |
| Patents: | 0 |
Pharmacology for NDA: 020983
| Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 020983
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983 | NDA | GlaxoSmithKline LLC | 0173-0682 | 0173-0682-20 | 1 INHALER in 1 CARTON (0173-0682-20) / 200 AEROSOL, METERED in 1 INHALER |
| VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983 | NDA | GlaxoSmithKline LLC | 0173-0682 | 0173-0682-24 | 1 INHALER in 1 CARTON (0173-0682-24) / 60 AEROSOL, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | EQ 0.09MG BASE/INH | ||||
| Approval Date: | Apr 19, 2001 | TE: | BX | RLD: | Yes | ||||
Expired US Patents for NDA 020983
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | VENTOLIN HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 020983-001 | Apr 19, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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