TAPENTADOL HYDROCHLORIDE | N203794 | COLLEGIUM PHARMACEUTICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma, LLC FDA-2023-P-4065 Novitium Pharma LLC filed this relisting petition under 21 C.F.R. §10.25(a), §10.30, and Sections 505(j) and 505(w) of the FDC Act requesting that the FDA determine whether the Reference Listed Drug Nucynta (Tapentadol Hydrochloride) Oral Solution Eq 20mg Base/ml, NDA 203794 owned by Collegium Pharm | 505(q) | 2023-09-20 | Withdrawn | Novitium Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| NPP | Jul 3, 2026 | Expired |
| PED | Jan 3, 2027 | < 1 year |