Details for New Drug Application (NDA): 021254
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NDA 021254 describes ADVAIR HFA, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the ADVAIR HFA profile page.
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.
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: | 1 |
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 | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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 | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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 | 021254-003 | Jun 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-002 | Jun 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-002 | Jun 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-002 | Jun 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-002 | Jun 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
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