OXYMETAZOLINE HYDROCHLORIDE | N212520 | RVL PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from RVL Pharmaceuticals, Inc. FDA-2021-P-0533 RVL Pharmaceuticals, Inc., the holder of NDA 212520 for UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1%, filed this citizen petition requesting that the FDA require comparative in vivo clinical studies with efficacy and safety endpoints, comparative in vivo pharmacokinetic studies, de | 505(q) | 2021-06-07 | Denied | RVL Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8357714 | Aug 26, 2031 | — | — | — | — | |
| 9867808 | Aug 26, 2031 | — | — | — | — | |
| 10799481 | Dec 16, 2039 | — | — | — | — | |
| 10814001 | Dec 16, 2039 | — | — | Yes | — | — |
| 10898573 | Dec 16, 2039 | — | — | Yes | — | — |
| 10912765 | Aug 26, 2031 | — | — | — | — | |
| 10940138 | Dec 16, 2039 | — | — | — | — | |
| 11103482 | Dec 16, 2039 | — | — | Yes | — | — |
| 11311515 | Dec 16, 2039 | — | — | Yes | — | — |
| 11324722 | Dec 16, 2039 | — | — | — | — | |
| 11541036 | Dec 16, 2039 | — | — | Yes | — | — |
| 11701343 | Dec 16, 2039 | — | — | — | — | |
| 12605363 | Dec 16, 2039 | — | — | Yes | — | — |
RVL Pharmaceuticals added U.S. Patent 12,605,363 to the Orange Book for UPNEEQ (oxymetazoline hydrochloride).
New: New record