Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

ency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. CARAFATE (sucralfate) oral suspension, 1 g/10 mL, is the subject of NDA 019183, held by Abbvie, Inc., and initially approved on December 16, 1993. CARAFATE is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. CARAFATE (sucralfate) oral suspension, 1 g/10 mL, is currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. Aurobindo Pharma USA, Inc., submitted a citizen petition dated July 6, 2026 (Docket No. FDA-2026-P-7537), under 21 CFR 10.30, requesting that the Agency determine whether CARAFATE (sucralfate) oral suspension, 1 g/10 mL, has been voluntarily withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under Sec. 314.161 that CARAFATE (sucralfate) oral suspension, 1 g/10 mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information