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Details for New Drug Application (NDA): 021457
The generic ingredient in PROAIR HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Thirty-five 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: | 4 |
Therapeutic Class: | Respiratory Tract Agents |
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 | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 49999-908 | N | 49999-908-85 |
PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457 | NDA | A-S Medication Solutions | 50090-1329 | N | 50090-1329-0 |
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: | BX | RLD: | Yes | ||||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Sep 12, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Sep 7, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ➤ Try a Free 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 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Teva Branded Pharm | PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457-001 | Oct 29, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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