AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | N022314 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-5163 The law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this Suitability Petition pursuant to 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 that an amlodipine, hydrochlorothiazide, and valsartan oral tablet in | Suitability | 2024-11-05 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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