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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212913

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NDA 212913 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 212913

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

Pharmacology for NDA: 212913

Medical Subject Heading (MeSH) Categories for 212913

Anti-Ulcer Agents

Suppliers and Packaging for NDA: 212913

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUCRALFATE	sucralfate	SUSPENSION;ORAL	212913	ANDA	Mylan Pharmaceuticals Inc.	0378-9205	0378-9205-35	420 mL in 1 BOTTLE, PLASTIC (0378-9205-35)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	1GM/10ML
Approval Date:	Sep 12, 2022	TE:	AB	RLD:	No

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