VANCOMYCIN HYDROCHLORIDE | N050671 | BAXTER HEALTHCARE CORP
| 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: 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 | Suitability | 2020-11-16 | Withdrawn | Lachman Consulting Services, Inc. |
Citizen Petition from Hyman, Phelps & McNamara on behalf of Xellia Pharmaceut... FDA-2019-P-1560 · 4 docket documents Law firm Hyman, Phelps & McNamara filed this citizen petition on behalf of Xellia Pharmaceuticals ApS and Xellia Pharmaceuticals USA, LLC requesting that the FDA assign a Therapeutic Equivalence Evaluation Code of "AP" in the Orange Book for Xellia's Vancomycin Injection in 500 mg/100 mL and 1 g/200 | 505(q) | 2019-04-03 | Open | Xellia Pharmaceuticals ApS and Xellia Pharmaceuticals USA, LLC. |
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 | — |
Suitability Petition Supplement from King & Spalding LLP FDA-2006-P-0344 · 5 docket documents 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 | Suitability | 2008-11-15 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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