METHYLENE BLUE | A216955 | STERISCIENCE PTE LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals (USA), Inc FDA-2023-P-5366 · 9 docket documents Zydus Pharmaceuticals (USA) Inc. filed this petition on December 6, 2023, requesting that the FDA investigate and take prompt enforcement actions against the unapproved Methylene Blue Injection manufactured by BPI labs and distributed by FFF. Zydus seeks removal of the unapproved product from the ma | Other | 2023-12-07 | Denied | Zydus Pharmaceuticals (USA), Inc |
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2023-P-5387 · 7 docket documents Zydus Pharmaceuticals (USA) Inc. filed this citizen petition on December 6, 2023, requesting that the FDA investigate and take prompt enforcement actions against unapproved methylene blue injection marketed by Cameron Pharmaceuticals and manufactured by Vitae Enim Vitae Scientific, Inc., alleging vi | Other | 2023-12-07 | Denied | Zydus Pharmaceuticals (USA) Inc. |
Suitability Petition Completeness Assessment Correspondence from FDA CDER to ... FDA-2023-P-4288 · 4 docket documents Pharmobedient Consulting, LLC filed a suitability petition under 21 C.F.R. §314.93(b) requesting permission to submit an Abbreviated New Drug Application for Methylene Blue Injection, 100 mg/10 mL. The FDA determined the petition complete and established an April 12, 2024 goal date for review under | Suitability | 2023-10-13 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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