Application 022371
- Type
- NDA
- Sponsor
- MEDA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ASTEPRO | AZELASTINE HYDROCHRLORIDE | SPRAY, METERED;NASAL | 0.1% | No | No |
| 002 | ASTEPRO | AZELASTINE HYDROCHRLORIDE | SPRAY, METERED;NASAL | 0.15% | No | No |
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 70817 | ORIG | 2009-08-31 |