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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212769

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NDA 212769 describes SUCRALFATE, which is a drug marketed by Abon Pharms Llc, Amneal, Cosette, Hikma, Mylan, Padagis Us, Pd Partners, Strides Pharma, Vistapharm Llc, Amneal Pharms, Chartwell Rx, Teva, and Zydus Lifesciences, and is included in thirteen NDAs. It is available from forty-five suppliers. Additional details are available on the SUCRALFATE profile page.

The generic ingredient in SUCRALFATE is sucralfate. There are fourteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the sucralfate profile page.

Summary for 212769

Tradename:	SUCRALFATE
Applicant:	Hikma
Ingredient:	sucralfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 212769

Anti-Ulcer Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	1GM/10ML
Approval Date:	Jul 23, 2024	TE:		RLD:	No

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