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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 209356

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NDA 209356 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 209356

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

Pharmacology for NDA: 209356

Medical Subject Heading (MeSH) Categories for 209356

Anti-Ulcer Agents

Suppliers and Packaging for NDA: 209356

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUCRALFATE	sucralfate	SUSPENSION;ORAL	209356	ANDA	AvKARE	42291-781	42291-781-42	420 mL in 1 BOTTLE (42291-781-42)
SUCRALFATE	sucralfate	SUSPENSION;ORAL	209356	ANDA	AvPAK	50268-745	50268-745-14	40 CUP in 1 BOX (50268-745-14) / 10 mL in 1 CUP (50268-745-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	1GM/10ML
Approval Date:	Dec 2, 2019	TE:	AB	RLD:	No

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