Application 017118
- Type
- NDA
- Sponsor
- ENDO PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SYMMETREL | AMANTADINE HYDROCHLORIDE | SYRUP; ORAL | 50MG/5ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| amantadine hydrochloride | AMANTADINE HYDROCHLORIDE | Proficient Rx LP | 743d1b73-f47e-4bbf-bb52-45b1e7f17308 | 2022-09-01 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
| Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Proficient Rx LP | f0e9b795-c0a1-4c95-928c-dacaaf9b3bb5 | 2019-10-01 | Warnings, Adverse reactions | AMANTADINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.