MESALAMINE | N020049 | TAKEDA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Shire Pharmaceuticals, Inc. - Citizen Petition FDA-2008-P-0507 · 9 docket documents Shire Pharmaceuticals, Inc. filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA require all Abbreviated New Drug Applications and Section 505(b)(2) applications for generic or follow-on formulations of Pentasa (mesalamine) | 505(q) | 2008-10-27 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$5.83
per ea
Lowest NADAC/Unit
$2.90
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 54092019112PENTASA 500 MG CAPSULE | $5.83 | EA | Brand | — | 2026-06-17 |
| 54092018981PENTASA 250 MG CAPSULE | $2.90 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.