amoxicillin · Us Antibiotics · NDA 050459, 050460, 050542, 050754, 050760, 050761
Amoxil
Earliest generic entry, as listed
Open now
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 · 13
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050459 · 001 · RLD · discontinued | capsule, oral | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050459 · 002 · RLD · discontinued | capsule, oral | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050460 · 001 · RLD · discontinued | for suspension, oral | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050460 · 002 · RLD · discontinued | for suspension, oral | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050460 · 005 · RLD · discontinued | for suspension, oral | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050542 · 001 · RLD · discontinued | tablet, chewable, oral | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050542 · 002 · RLD · discontinued | tablet, chewable, oral | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050754 · 001 · RLD · discontinued | tablet, oral | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050754 · 002 · RLD · discontinued | tablet, oral | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050760 · 001 · RLD · discontinued | for suspension, oral | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050760 · 002 · RLD | for suspension, oral | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050761 · 001 · discontinued | tablet, chewable, oral | 200MG | open |
| 050761 · 002 · discontinued | tablet, chewable, oral | 400MG | open |