AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is Azelastine Hydrochloride; Fluticasone Propionate.
| Product ID | 45802-066_11c1846d-ea52-4041-812e-1ef1ee30d6e5 |
| NDC | 45802-066 |
| Product Type | Human Prescription Drug |
| Proprietary Name | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE |
| Generic Name | Azelastine Hydrochloride, Fluticasone Propionate |
| Dosage Form | Spray, Metered |
| Route of Administration | NASAL |
| Marketing Start Date | 2021-03-01 |
| Marketing Category | ANDA / |
| Application Number | ANDA208111 |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| Substance Name | AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE |
| Active Ingredient Strength | 137 ug/1; ug/1 |
| Pharm Classes | Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-03-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-3458 | Azelastine Hydrochloride and Fluticasone Propionate | Azelastine Hydrochloride and Fluticasone Propionate |
| 45802-066 | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | azelastine hydrochloride, fluticasone propionate |
| 60505-0953 | Azelastine hydrochloride and Fluticasone propionate | Azelastine hydrochloride and Fluticasone propionate |
| 63629-8612 | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | azelastine hydrochloride, fluticasone propionate |
| 0037-0245 | DYMISTA | Azelastine Hydrochloride and Fluticasone Propionate |
| 69621-812 | Ticalast | azelastine hydrochloride and fluticasone propionate |