BALSALAZIDE DISODIUM | A077806 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Salix Pharmaceuticals, Inc. FDA-2005-P-0314 · 9 docket documents Salix Pharmaceuticals, Inc. filed this petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA establish guidance or regulations providing bioequivalence requirements for oral locally-acting gastrointestinal drug products prior to approval of generic version | 505(q) | 2011-03-10 | Denied | Salix Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.3597
per ea
Lowest NADAC/Unit
$0.3597
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00054007928BALSALAZIDE DISODIUM 750 MG CP | $0.3597 | EA | Generic | — | 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.