Application 202609
- Type
- ANDA
- Sponsor
- UPSHER SMITH LABS
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 |
|---|---|---|---|---|---|
| 0832-0290 | Azelastine Hydrochloride | Azelastine Hydrochloride | Upsher-Smith Laboratories, Inc. | ANDA | Current |