MELOXICAM | N211210 | TERSERA THERAPEUTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pharmobedient Consulting, LLC FDA-2023-P-4279 Pharmobedient Consulting, LLC filed a citizen petition under Section 505(j) requesting that the FDA determine whether QMIIZ ODT (meloxicam) orally disintegrating tablets 7.5 mg and 15 mg, referenced under NDA 211210 held by Tersera, was withdrawn from commercial distribution for safety or effectiven | 505(q) | 2023-10-03 | Withdrawn | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8545879 | Aug 31, 2030 | — | — | Yes | — | — |