amantadine hydrochloride · Endo Pharms · NDA 016020, 016023, 018101
Symmetrel
Earliest generic entry, as listed · earliest of 3 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 016020 · 001 · RLD · discontinued | capsule, oral | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 016023 · 002 · RLD · discontinued | syrup, oral | 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018101 · 001 · RLD · discontinued | tablet, oral | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |