SUCRALFATE | A070848 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Vertice Pharma Management Corp FDA-2018-P-1310 · 44 docket documents Vertice Pharma Management Corp filed this citizen petition on March 28, 2018, requesting that the FDA revise its Draft Guidance for Sucralfate Oral Suspension to eliminate the requirement that generic sucralfate oral suspension formulations be quantitatively identical to Carafate (the reference list | 505(q) | 2018-03-29 | Denied | Vertice Pharma Management Corp |
Citizen Petition from Haynes and Boone, LLP FDA-2017-P-6922 · 9 docket documents Haynes and Boone, LLP, on behalf of Vertice Pharma LLC, filed this citizen petition requesting that the FDA deny approval to any ANDA for sucralfate oral suspension that relies on patient-based clinical endpoint studies to establish bioequivalence with Carafate (sucralfate) oral suspension as the re | 505(q) | 2017-12-20 | Denied | Haynes and Boone, LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1830
per ea
Lowest NADAC/Unit
$0.1830
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093221001SUCRALFATE 1 GM TABLET | $0.1830 | EA | Generic | — | 2026-06-17 |
| 00093221005SUCRALFATE 1 GM TABLET | $0.1830 | EA | Generic | — | 2026-06-17 |
| 00093221098SUCRALFATE 1 GM TABLET | $0.1830 | EA | Generic | — | 2026-06-17 |
| 51079075320SUCRALFATE 1 GM TABLET | $0.1830 | 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.