VANCOMYCIN | N213895 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - Vancomycin Hydrochloride for Injection, USP RE Suitability Pet... FDA-2023-P-4334 · 7 docket documents 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. | Suitability | 2023-10-04 | Granted | Hospira, Inc |
Attachment 3 Therapeutic monitoring of vancomycin for serious
methicillin-
re... FDA-2021-P-1081 · 7 docket documents | Suitability | 2021-10-06 | Withdrawn | Hyman, Phelps & McNamara, P.C. |
ATTACHMENT 3: Draft Package Insert Proposed for Vancomycin Hydrochloride for ... FDA-2020-P-2187 · 6 docket documents 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. | Suitability | 2020-11-16 | Withdrawn | Lachman Consulting Services, Inc. |
Olsson, Frank, Weeda (OFW) et al Law PC - Citizen Petition FDA-2013-P-1202 · 3 docket documents On September 26, 2013, the law firm Olsson Frank Weeda Terman Matz PC filed a citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine a new strength of Vancomycin Hydrochloride For Injection, USP (1.5 grams base per vial) is suitable | Other | 2013-10-28 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.