Details for New Drug Application (NDA): 021254
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The generic ingredient in ADVAIR HFA is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 021254
Tradename: | ADVAIR HFA |
Applicant: | Glaxo Grp Ltd |
Ingredient: | fluticasone propionate; salmeterol xinafoate |
Patents: | 0 |
Pharmacology for NDA: 021254
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 021254
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254 | NDA | GlaxoSmithKline LLC | 0173-0715 | 0173-0715-20 | 1 INHALER in 1 CARTON (0173-0715-20) / 120 AEROSOL, METERED in 1 INHALER |
ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254 | NDA | GlaxoSmithKline LLC | 0173-0715 | 0173-0715-22 | 1 INHALER in 1 CARTON (0173-0715-22) / 60 AEROSOL, METERED in 1 INHALER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.045MG/INH;EQ 0.021MG BASE/INH | ||||
Approval Date: | Jun 8, 2006 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.115MG/INH;EQ 0.021MG BASE/INH | ||||
Approval Date: | Jun 8, 2006 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.23MG/INH;EQ 0.021MG BASE/INH | ||||
Approval Date: | Jun 8, 2006 | TE: | RLD: | Yes |
Expired US Patents for NDA 021254
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-002 | Jun 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-003 | Jun 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-001 | Jun 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-003 | Jun 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-003 | Jun 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
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