Details for New Drug Application (NDA): 021457
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The generic ingredient in PROAIR 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 021457
Tradename: | PROAIR HFA |
Applicant: | Teva Branded Pharm |
Ingredient: | albuterol sulfate |
Patents: | 9 |
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 AUTHORIZED GENERIC | 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 | NuCare Pharmaceuticals,Inc. | 68071-4940 | 68071-4940-2 | 200 AEROSOL, METERED in 1 BOX (68071-4940-2) |
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: | ⤷ Sign Up | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 021457
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