OLMESARTAN MEDOXOMIL | N021286 | COSETTE PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen FDA-2017-P-6513 · 14 docket documents Public Citizen, a consumer advocacy organization, filed this petition on November 15, 2017 under Section 355(e) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA immediately remove from the market all medications containing olmesartan medoxomil (marketed as Benicar, Benicar HCT, Az | Other | 2017-11-16 | Denied | Public Citizen |
Citizen Petition from Gordon Johnston Regulatory Consultants, LLC FDA-2016-P-0644 · 6 docket documents Gordon Johnston Regulatory Consultants, LLC filed this citizen petition under section 505(j)(2)(C) requesting that the FDA determine Olmesartan Medoxomil Tablets at a 10 mg strength is suitable for submission as an abbreviated new drug application, with the reference listed drug being Benicar tablet | Other | 2016-03-31 | Granted | Gordon Johnston Regulatory Consultants, LLC |
Citizen Petition Request from LACHMAN CONSULTANT SERVICES INC FDA-2015-P-0596 · 6 docket documents Lachman Consultant Services, Inc. filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Olmesartan Medoxomil Tablets, 10 mg, may be submitted as an abbreviated new drug application, with the reference listed | Other | 2015-02-25 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$17.24
per ea
Lowest NADAC/Unit
$10.13
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00713086230BENICAR 40 MG TABLET | $17.24 | EA | Brand | $0.1101 | 2026-07-01 |
| 00713094230BENICAR 40 MG TABLET | $17.24 | EA | Brand | $0.1101 | 2026-07-01 |
| 00713086130BENICAR 20 MG TABLET | $12.32 | EA | Brand | $0.0796 | 2026-07-01 |
| 00713094130BENICAR 20 MG TABLET | $12.32 | EA | Brand | $0.0796 | 2026-07-01 |
| 00713086030BENICAR 5 MG TABLET | $10.13 | EA | Brand | $0.0563 | 2026-07-01 |
| 00713094030BENICAR 5 MG TABLET | $10.13 | EA | Brand | $0.0563 | 2026-07-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.