fluticasone propionate and salmeterol is a Respiratory (inhalation) Powder in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Salmeterol Xinafoate; Fluticasone Propionate.
| Product ID | 0054-0326_32d95c20-7a4e-40d8-8c65-812bc88599c4 |
| NDC | 0054-0326 |
| Product Type | Human Prescription Drug |
| Proprietary Name | fluticasone propionate and salmeterol |
| Generic Name | Fluticasone Propionate And Salmeterol |
| Dosage Form | Powder |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2020-12-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203433 |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Substance Name | SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE |
| Active Ingredient Strength | 50 ug/1; ug/1 |
| Pharm Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2020-12-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0326 | fluticasone propionate and salmeterol | fluticasone propionate and salmeterol |
| 0054-0327 | fluticasone propionate and salmeterol | fluticasone propionate and salmeterol |
| 0093-3607 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol |
| 0093-3608 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol |
| 0093-3609 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol |
| 0093-7516 | fluticasone propionate and salmeterol | fluticasone propionate and salmeterol |
| 0093-7517 | fluticasone propionate and salmeterol | fluticasone propionate and salmeterol |
| 0093-7518 | fluticasone propionate and salmeterol | fluticasone propionate and salmeterol |
| 50090-3387 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol |
| 50090-3271 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol |
| 50090-3272 | Fluticasone Propionate and Salmeterol | Fluticasone Propionate and Salmeterol |
| 0173-0695 | ADVAIR | fluticasone propionate and salmeterol |