VANCOMYCIN HYDROCHLORIDE | N209481 | MYLAN LABORATORIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hospira, Inc. FDA-2024-P-2085 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 | Open | Hospira |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-1081 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 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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