Details for New Drug Application (NDA): 203433
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NDA 203433 describes FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, which is a drug marketed by Hikma and Teva Pharms Usa and is included in two NDAs. It is available from three suppliers. Additional details are available on the FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE profile page.
The generic ingredient in FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 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 FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 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 203433
| Tradename: | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
| Applicant: | Hikma |
| Ingredient: | fluticasone propionate; salmeterol xinafoate |
| Patents: | 0 |
Pharmacology for NDA: 203433
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 203433
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 203433 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0326 | 0054-0326-56 | 1 POUCH in 1 CARTON (0054-0326-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 203433 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0327 | 0054-0327-56 | 1 POUCH in 1 CARTON (0054-0327-56) / 1 INHALER in 1 POUCH / 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: | Dec 17, 2020 | 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: | Dec 17, 2020 | 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: | Dec 19, 2023 | TE: | AB | RLD: | No | ||||
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