Application 207610
- Type
- ANDA
- Sponsor
- HI TECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | EQ 0.125MG BASE/SPRAY | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50383-738 | Azelastine Hydrochloride | Azelastine Hydrochloride | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-738 | Azelastine Hydrochloride | Azelastine Hydrochloride | Akorn | ANDA | Current |
| 50383-738 | Azelastine Hydrochloride | Azelastine Hydrochloride | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |