VALACYCLOVIR HYDROCHLORIDE | N020487 | GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-0434 Senores Pharmaceuticals, Inc. submitted this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Valacyclovir Hydrochloride Tablets in 250 mg and 750 mg strengths suitable for submission in an ANDA, based on the reference listed | Suitability | 2025-02-13 | Open | Senores Pharmaceuticals |
Citizen Petition from Jubilant Generics Limited FDA-2017-P-7034 Jubilant Generics Limited filed this petition pursuant to section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.93, requesting that the FDA determine Valacyclovir Hydrochloride Oral Tablet in strengths equivalent to 250 mg and 750 mg base are suitable for submission as an AN | Other | 2017-12-29 | Open | Jubilant Generics Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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