ASCOR

FDA-2024-P-4461 · 8 docket documents

Maiva Pharma Private Limited submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval of a suitability petition to allow submission of an ANDA for Ascorbic Acid Injection, USP in single-dose vial strengths of 50 mg/2 mL, 100 mg/4

FDA-2022-P-0979 · 6 docket documents

ArentFox Schiff LLP filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Ascorbic Acid Injection, USP in 2,500 mg/5 mL and 5,000 mg/10 mL presentations (500 mg/mL concentration) suitable for submission in an ANDA, with

FDA-2021-P-0345 · 6 docket documents

BPI Labs, LLC submitted this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an Abbreviated New Drug Application for Ascorbic Acid Injection 5000 mg/10 mL (500 mg/mL), which differs from the reference listed drug ASCOR (NDA 209112) only in fill volume,

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