POSACONAZOLE | N214770 | MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Reyoung Pharmaceutical Co., Ltd. FDA-2023-P-5675 Reyoung Pharmaceutical Co., Ltd. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act on December 25, 2023, requesting that the FDA declare posaconazole for delayed-release oral suspension, USP, 300 mg suitable for submission as an Abbreviated New Drug A | Suitability | 2023-12-26 | Open | Reyoung Pharmaceutical Co. |
Suitability Petition from Reyoung Pharmaceutical Co., Ltd. FDA-2023-P-1227 Reyoung Pharmaceutical Co., Ltd. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare posaconazole for delayed-release oral suspension, USP, 300 mg suitable for submission as an ANDA, with the only proposed change from | Suitability | 2023-03-31 | Open | Reyoung Pharmaceutical Co. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| I-984 | Jan 27, 2029 | Active |