VANCOMYCIN HYDROCHLORIDE | N209481 | MYLAN LABORATORIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hospira, Inc. FDA-2024-P-2085 · 7 docket documents Hospira, Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that Vancomycin Hydrochloride for Injection, USP, ADD-Vantage® Vial, 1.25 grams (base)/vial is suitable for submission as an additional strength und | Suitability | 2024-04-26 | DeniedDecision letter not yet read | Hospira, Inc. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-1081 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Vancomycin Hydrochloride for Injection in 1.75 g/vial and 2 g/vial strengths suitable for submission as an ANDA | Suitability | 2021-10-06 | WithdrawnUnverified summary | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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