Application 216421
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZELASTINE HYDROCHLORIDE ALLERGY | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No |
| 002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78841 | ORIG | 2024-06-20 |