AMLODIPINE BESYLATE; VALSARTAN | N021990 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pfizer Inc FDA-2007-P-0350 · 6 docket documents Pfizer Inc submitted this citizen petition on March 21, 2007, requesting that the FDA rescind final approval of Novartis's NDA 20-364 for Lotrel (amlodipine besylate and benazepril hydrochloride) and withhold approval of any supplemental NDAs, arguing that the Lotrel NDA should be reclassified as a | 505(q) | 2008-05-23 | Denied | Pfizer Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$15.39
per ea
Lowest NADAC/Unit
$10.65
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00078049115EXFORGE 10-320 MG TABLET | $15.39 | EA | Brand | $0.5512 | 2026-01-07 |
| 00078048815EXFORGE 5-160 MG TABLET | $10.65 | EA | Brand | $0.3721 | 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.