FOLIC ACID | N216395 | SOLUBIOMIX LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Method Pharmaceuticals LLC FDA-2024-P-0422 Method Pharmaceuticals LLC filed an ANDA suitability petition amendment under Section 505(j)(2)(C) of the FDC Act and 21 C.F.R. §314.93 requesting FDA authorization to submit an ANDA for Folic Acid Oral Solution at 0.1 mg/mL and 1 mg/mL strengths, which would differ in dosage form and strength from | Suitability | 2024-03-11 | Granted | — |
Suitability Petition Amendment from Method Pharmaceuticals, LLC FDA-2024-P-0422 Method Pharmaceuticals LLC filed this ANDA suitability petition under section 505(j)(2)(C) requesting permission to file an Abbreviated New Drug Application for Folic Acid Oral Solution in two strengths (0.1 mg/mL and 1 mg/mL), and sought a waiver of pediatric assessment requirements under the Pedia | Suitability | 2024-02-26 | Granted | — |
Buchanan Ingersoll & Rooney PC - Citizen Petition FDA-2009-P-0587 Buchanan Ingersoll & Rooney PC filed this citizen petition on December 8, 2009, requesting that the FDA Commissioner issue an order confirming that certain prescription prenatal vitamins containing 1 mg to 4 mg of folic acid, indicated for reducing neural tube defect risks, are generally recognized | Other | 2009-12-14 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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