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Details for New Drug Application (NDA): 021457
NDA 021457 describes PROAIR HFA, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from twelve suppliers. There are six 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-eight 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-eight 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: | 6 |
| 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 | Rebel Distributors Corp | 21695-851 | 21695-851-85 | 200 AEROSOL, METERED in 1 INHALER (21695-851-85) |
| PROAIR HFA | albuterol sulfate | AEROSOL, METERED;INHALATION | 021457 | NDA | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 49999-908 | 49999-908-85 | 200 AEROSOL, METERED in 1 INHALER (49999-908-85) |
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: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Sep 12, 2023 | 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 |
| 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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