Application 213872
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 205.5MCG/SPRAY | Yes | No |
| 002 | CHILDREN?S ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 205.5MCG/SPRAY | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0280-0065 | Astepro Allergy | Azelastine HCl | Bayer HealthCare LLC. | NDA | Current |
| 0280-0066 | Children Astepro Allergy | Azelastine HCl | Bayer HealthCare LLC. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83962 | SUPPL | 2025-10-28 |
| 83958 | SUPPL | 2025-10-28 |
| 76664 | SUPPL | 2023-11-24 |
| 76638 | SUPPL | 2023-11-21 |
| 70962 | ORIG | 2022-05-04 |
| 69908 | SUPPL | 2022-01-19 |
| 67845 | ORIG | 2021-06-21 |
| 67844 | ORIG | 2021-06-21 |