Application 020114
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ASTELIN | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | EQ 0.125MG BASE/SPRAY | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0037-0241 | Astelin | azelastine hydrochloride | Meda Pharmaceuticals | NDA | Current |
| 50090-2538 | Azelastine Hydrochloride | Azelastine Hydrochloride | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 51525-0294 | Azelastine Hydrochloride | Azelastine Hydrochloride | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0294 | Azelastine Hydrochloride | Azelastine Hydrochloride | Wallace Pharmaceuticals Inc. | NDA | Current |
| 51525-0294 | Azelastine Hydrochloride | Azelastine Hydrochloride | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-0294 | Azelastine Hydrochloride | Azelastine Hydrochloride | Wallace Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57639 | ORIG | 2019-02-15 |
| 55433 | SUPPL | 2018-09-12 |
| 34270 | SUPPL | 2014-11-13 |
| 21169 | SUPPL | 2014-10-24 |
| 34269 | SUPPL | 2012-01-24 |
| 2026 | SUPPL | 2012-01-23 |
| 21168 | SUPPL | 2007-08-14 |
| 20475 | SUPPL | 2004-05-27 |
| 2025 | SUPPL | 2000-09-15 |
| 21167 | SUPPL | 2000-05-30 |