SUCRALFATE | N019183 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA Inc FDA-2026-P-7537 · 3 docket documents Aurobindo Pharma USA Inc filed this citizen petition under Section 505(j) requesting that the FDA determine whether CARAFATE (sucralfate) oral suspension 1 g/10 mL, NDA 019183, originally approved for AbbVie Inc, was withdrawn from sale for reasons of safety or effectiveness, as the product now appe | 505(q) | 2026-07-07 | Open | Aurobindo Pharma USA Inc |
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Vertice Pharma Management Corp filed this citizen petition on March 28, 2018, requesting that the FDA revise its Draft Guidance for Sucralfate Oral Suspension to eliminate the requirement that generic sucralfate oral suspension formulations be quantitatively identical to Carafate (the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
$0.1174
per ml
Lowest NADAC/Unit
$0.1174
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 82182010614SUCRALFATE 1 GM/10 ML SUSP | $0.1174 | ML | 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.