Details for New Drug Application (NDA): 021077
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NDA 021077 describes ADVAIR DISKUS 500/50, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from five suppliers. Additional details are available on the ADVAIR DISKUS 500/50 profile page.
The generic ingredient in ADVAIR DISKUS 500/50 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 DISKUS 500/50 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 021077
| Tradename: | ADVAIR DISKUS 500/50 |
| Applicant: | Glaxo Grp Ltd |
| Ingredient: | fluticasone propionate; salmeterol xinafoate |
| Patents: | 0 |
Pharmacology for NDA: 021077
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 021077
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077 | NDA | GlaxoSmithKline LLC | 0173-0695 | 0173-0695-00 | 1 INHALER in 1 CARTON (0173-0695-00) / 60 POWDER in 1 INHALER |
| ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077 | NDA | GlaxoSmithKline LLC | 0173-0695 | 0173-0695-04 | 1 INHALER in 1 CARTON (0173-0695-04) / 14 POWDER in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.1MG/INH;EQ 0.05MG BASE/INH | ||||
| Approval Date: | Aug 24, 2000 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.25MG/INH;EQ 0.05MG BASE/INH | ||||
| Approval Date: | Aug 24, 2000 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.5MG/INH;EQ 0.05MG BASE/INH | ||||
| Approval Date: | Aug 24, 2000 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021077
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