POSACONAZOLE | N205053 | MERCK SHARP AND DOHME CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC. et al 1 patentANDA 207355Posaconazole | D.N.J. | 2015-08-06 | Terminated 2017-09-29 | — |
| D. Del. | 2015-05-29 | Terminated 2019-07-26 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - Draft Package Insert Proposed for posaconazole for delayed-rel... FDA-2023-P-1227 Reyoung Pharmaceutical Co., Ltd. filed a Suitability Petition regarding posaconazole for delayed-release oral suspension, USP, 100 mg, and submitted a draft package insert for the product as part of the petition. | Suitability | 2023-03-31 | Open | Reyoung Pharmaceutical Co. |
Attachment 1 - Current labeling for NOXAFIL® (posaconazole) delayed-release t... FDA-2023-P-1227 Reyoung Pharmaceutical Co., Ltd. filed a suitability petition regarding posaconazole delayed-release tablets 100 mg (NOXAFIL), an NDA product held by Merck Sharp and Dohme Corp under NDA 205053, though the specific requested action is not detailed in the provided text. | Suitability | 2023-03-31 | Open | Reyoung Pharmaceutical Co. |
Suitability Petition from Reyoung Pharmaceutical Co Ltd FDA-2022-P-1833 Reyoung Pharmaceutical Co., Ltd. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to submit an ANDA for posaconazole delayed-release oral suspension, 100 mg, which differs from the reference listed drug NOXAFIL delayed-release tablets, 100 mg (NDA 20 | Suitability | 2022-08-09 | Open | Reyoung Pharmaceutical Co Ltd |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| NPP | Jan 27, 2029 | Active |
| ODE-355 | Jun 17, 2028 | Active |