TESTOSTERONE UNDECANOATE | N206089 | TOLMAR INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Clarus Therapeutics, Inc. FDA-2019-P-4644 Clarus Therapeutics, Inc. filed this citizen petition under Sections 505(b), 505(j), and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA issue written guidance establishing clear safety and efficacy standards for oral testosterone-ester prodrugs as testosterone replacement the | 505(q) | 2019-10-09 | Denied | Clarus Therapeutics |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8241664 | Mar 29, 2029 | — | — | Yes | — | |
| 8492369 | Dec 20, 2030 | — | — | Yes | — | |
| 8778916 | Apr 12, 2030 | — | — | Yes | — | — |
| 10543219 | Apr 12, 2030 | — | — | — | — | |
| 10617696 | Apr 12, 2030 | — | Yes | Yes | — | — |
| 11179402 | Apr 14, 2026 | — | Yes | Yes | — | — |
| 11179403 | Apr 12, 2030 | — | — | — | — | |
| 11331325 | Jan 6, 2027 | — | — | — | — | |
| 11426416 | Apr 12, 2030 | — | — | — | — | |
| 11564933 | Apr 12, 2039 | — | — | — | — | |
| 12605391 | Apr 12, 2039 | — | — | — | — |