ASCORBIC ACID | A217131 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Exhibit 2 - Proposed Package Insert for Ascorbic Acid Injection, USP, 2,500 m... FDA-2022-P-0979 · 6 docket documents ArentFox Schiff LLP filed a citizen petition regarding ascorbic acid injection in various concentrations (2,500 mg/5 mL, 5,000 mg/10 mL, and 25,000 mg/50 mL vials), requesting FDA suitability determination for the proposed package insert labeling for these injectable ascorbic acid products. | Suitability | 2022-06-06 | Granted | ArentFox Schiff LLP |
Attachment 3 - Highlights of Prescribing Information for Ascorbic acid inject... FDA-2021-P-0345 · 6 docket documents BPI Labs, LLC filed a suitability petition regarding ascorbic acid injection, which appears to involve a request for regulatory approval or recognition of the drug product's suitability for marketing as an NDA or ANDA. The attachment provided contains only prescribing information highlights and does | Suitability | 2021-04-01 | Withdrawn | BPI Labs, LLC |
Citizen Petition from Yoon Ja Kim FDA-2006-P-0017 · 6 docket documents Yoon Ja Kim filed this citizen petition requesting that the FDA Commissioner support Slo-C Dough Improver, a slow-acting ascorbic acid product, as a functional replacement for potassium bromate in bread production, citing animal bioassay evidence from the 1980s showing potassium bromate induced canc | Other | 2008-06-24 | Open | Yoon Ja Kim |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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