Details for New Drug Application (NDA): 208891
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NDA 208891 describes WIXELA INHUB, which is a drug marketed by Mylan and is included in one NDA. It is available from two suppliers. Additional details are available on the WIXELA INHUB profile page.
The generic ingredient in WIXELA INHUB 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 WIXELA INHUB 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 208891
| Tradename: | WIXELA INHUB |
| Applicant: | Mylan |
| Ingredient: | fluticasone propionate; salmeterol xinafoate |
| Patents: | 0 |
Pharmacology for NDA: 208891
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208891
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WIXELA INHUB | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208891 | ANDA | Mylan Pharmaceuticals Inc. | 0378-9320 | 0378-9320-32 | 1 INHALER in 1 CARTON (0378-9320-32) / 60 POWDER in 1 INHALER |
| WIXELA INHUB | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208891 | ANDA | Mylan Pharmaceuticals Inc. | 0378-9321 | 0378-9321-32 | 1 INHALER in 1 CARTON (0378-9321-32) / 60 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: | Jan 30, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.25MG/INH;EQ 0.05MG BASE/INH | ||||
| Approval Date: | Jan 30, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.5MG/INH;EQ 0.05MG BASE/INH | ||||
| Approval Date: | Jan 30, 2019 | TE: | AB | RLD: | No | ||||
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