Last Updated: August 2, 2026

Details for New Drug Application (NDA): 217126

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NDA 217126 describes SUCRALFATE, which is a drug marketed by Abon Pharms Llc, Amneal, Cosette Pharms Nc, Glenmark Pharms Ltd, Hikma, Mylan, Padagis Us, Pd Partners, Strides Pharma, Vistapharm Llc, Amneal Pharms, Chartwell Rx, Teva, and Zydus Lifesciences, and is included in fourteen NDAs. It is available from forty-four 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-seven suppliers are listed for this compound. Additional details are available on the sucralfate profile page.

Summary for 217126

Tradename:	SUCRALFATE
Applicant:	Cosette Pharms Nc
Ingredient:	sucralfate
Patents:	0

Pharmacology for NDA: 217126

Medical Subject Heading (MeSH) Categories for 217126

Anti-Ulcer Agents

Suppliers and Packaging for NDA: 217126

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUCRALFATE	sucralfate	SUSPENSION;ORAL	217126	ANDA	Cosette Pharmaceuticals, Inc.	0713-0791	0713-0791-75	420 mL in 1 BOTTLE (0713-0791-75)
SUCRALFATE	sucralfate	SUSPENSION;ORAL	217126	ANDA	Safecor Health, LLC	48433-226	48433-226-40	40 CUP, UNIT-DOSE in 1 CASE (48433-226-40) / 10 mL in 1 CUP, UNIT-DOSE (48433-226-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	1GM/10ML
Approval Date:	Nov 13, 2024	TE:	AB	RLD:	No

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