Application 090423
- Type
- ANDA
- Sponsor
- SUN PHARM
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 |
|---|---|---|---|---|---|
| 47335-779 | Azelastine Hydrochloride | Azelastine Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53002-2279 | Azelastine Hydrochloride | Azelastine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |