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 · 7 docket documents 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 | Denied | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$15.45
per ea
Lowest NADAC/Unit
$15.45
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00078056315EXFORGE HCT 10-320-25 MG TAB | $15.45 | EA | Brand | $8.01 | 2026-01-07 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.