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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 209356

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NDA 209356 describes SUCRALFATE, which is a drug marketed by Amneal, Mylan, Pd Partners, Vistapharm, Amneal Pharms, Nostrum Labs Inc, Teva, and Zydus Lifesciences, and is included in eight NDAs. It is available from thirty-three 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 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
Formulation / Manufacturing:	see details

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	50268-732	50268-732-12	20 CUP in 1 BOX (50268-732-12) / 10 mL in 1 CUP (50268-732-11)

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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