VANCOCIN HYDROCHLORIDE

FDA-2023-P-4334

Hospira, Inc. filed a citizen petition requesting that the FDA declare vancomycin hydrochloride for injection, USP as suitable for use in the pharmaceutical compendium, addressing regulatory requirements for this injectable antibiotic product.

FDA-2023-P-4334

Hospira, Inc. filed a citizen petition requesting that the FDA amend the United States Pharmacopeia monograph for Vancomycin Hydrochloride for Injection, USP to modify the related substances (RE) suitability requirements for the high-performance liquid chromatography analytical method used to test t

FDA-2020-P-2187

Lachman Consulting Services, Inc. filed a suitability petition regarding vancomycin hydrochloride oral solution 250 mg per 5 mL manufactured by ANI Pharmaceuticals Inc. under ANDA A061667. The petition concerns the current FDA-approved labeling for this product.

FDA-2020-P-2187

Lachman Consulting Services, Inc. filed a citizen petition requesting FDA approval to add a new strength of 125 mg (base)/5 mL to the vancomycin hydrochloride oral solution product line, with the submission including a draft package insert for the proposed additional strength formulation.

FDA-2006-P-0344

King & Spalding LLP filed supplements to two suitability petitions for Vancomycin HCl USP 750 mg formulations in both Fliptop Vial and ADD-Vantage Vial presentations. The petitioner requested FDA approval under 21 U.S.C. § 355(j)(2)(C) to establish these intermediate-strength vials as suitable for a