METHYLENE BLUE | N204630 | PROVEPHARM SAS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Amivas, Inc. FDA-2024-P-1913 Amivas, Inc. filed this citizen petition under 21 CFR 314.93 requesting permission to submit an ANDA for Methylene Blue Injection, USP (proposed name AMIVAS BLUE) at a strength of 50 mg/5 mL (10 mg/mL) for intravenous injection, which differs from the reference listed drug ProvayBlue® (NDA 204630) o | Suitability | 2024-04-18 | Open | Amivas |
Suitability Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2024-P-0227 Zydus Pharmaceuticals (USA) Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting FDA approval to submit an Abbreviated New Drug Application for Methylene Blue Injection, USP, 5 mg/1 mL, a new strength of th | Suitability | 2024-01-12 | Open | Zydus Pharmaceuticals (USA) Inc. |
Suitability Petition from Pharmobedient Consulting, LLC. FDA-2023-P-4288 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Methylene Blue Injection, 1% (10 mg/mL) suitable for submission in an Abbreviated New Drug Application, with the reference listed drug | Suitability | 2023-10-03 | Open | Pharmobedient Consulting |
Suitability Petition Petition from Lachman Consultants Inc. FDA-2022-P-0200 Lachman Consultants Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Methylene Blue Injection, USP, 5 mg/1 mL suitable for submission as an ANDA, with PROVAYBLUE (methylene blue) injection USP 5 mg/mL as the r | Suitability | 2022-02-18 | Open | Lachman Consultants Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| M-303 | Jan 8, 2027 | < 1 year |