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Details for New Drug Application (NDA): 021457
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NDA 021457 describes PROAIR HFA, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from ten suppliers. There are nine patents protecting this drug. Additional details are available on the PROAIR HFA profile page.
The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 021457
| Tradename: | PROAIR HFA |
| Applicant: | Teva Branded Pharm |
| Ingredient: | albuterol sulfate |
| Patents: | 9 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021457
| Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 021457
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457 | NDA | Teva Pharmaceuticals USA, Inc. | 0093-3174 | 0093-3174-31 | 1 INHALER in 1 CARTON (0093-3174-31) > 200 AEROSOL, METERED in 1 INHALER |
| PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457 | NDA | A-S Medication Solutions | 50090-1329 | 50090-1329-0 | 1 INHALER in 1 CARTON (50090-1329-0) > 200 AEROSOL, METERED in 1 INHALER |
Paragraph IV (Patent) Challenges for 021457
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROAIR HFA | AEROSOL, METERED;INHALATION | albuterol sulfate | 021457 | 2012-05-18 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | EQ 0.09MG BASE/INH | ||||
| Approval Date: | Oct 29, 2004 | TE: | AB2 | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 021457
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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