Application 022203
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ASTEPRO | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | EQ 0.125MG BASE/SPRAY | No | No |
| 002 | ASTEPRO | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | EQ 0.1876MG BASE/SPRAY | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0037-0242 | Astepro | Azelastine Hydrochloride | Meda Pharmaceuticals | NDA | Current |
| 0037-0243 | Astepro | Azelastine Hydrochloride | Meda Pharmaceuticals | NDA | Current |
| 0037-0243 | Astepro | Azelastine Hydrochloride | Meda Pharmaceuticals | NDA | Current |
| 51525-0234 | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0234 | Azelastine Hydrochloride | azelastine hydrochloride | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0234 | Azelastine Hydrochloride | azelastine hydrochloride | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |