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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216474

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NDA 216474 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 216474

Tradename:	SUCRALFATE
Applicant:	Strides Pharma
Ingredient:	sucralfate
Patents:	0

Pharmacology for NDA: 216474

Medical Subject Heading (MeSH) Categories for 216474

Anti-Ulcer Agents

Suppliers and Packaging for NDA: 216474

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUCRALFATE	sucralfate	SUSPENSION;ORAL	216474	ANDA	Strides Pharma Science Limited	64380-149	64380-149-01	420 mL in 1 BOTTLE, PLASTIC (64380-149-01)
SUCRALFATE	sucralfate	SUSPENSION;ORAL	216474	ANDA	Strides Pharma Science Limited	64380-149	64380-149-03	5 CUP, UNIT-DOSE in 1 TRAY (64380-149-03) / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	1GM/10ML
Approval Date:	May 21, 2024	TE:	AB	RLD:	No

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