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Last Updated: November 16, 2024

Details for New Drug Application (NDA): 215576

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NDA 215576 describes SUCRALFATE, which is a drug marketed by Abon Pharms Llc, Amneal, Hikma, Mylan, Pd Partners, Strides Pharma, Vistapharm Llc, Amneal Pharms, Nostrum Labs Inc, Teva, and Zydus Lifesciences, and is included in eleven NDAs. It is available from thirty-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-one suppliers are listed for this compound. Additional details are available on the sucralfate profile page.

Summary for 215576

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

Pharmacology for NDA: 215576

Medical Subject Heading (MeSH) Categories for 215576

Anti-Ulcer Agents

Suppliers and Packaging for NDA: 215576

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUCRALFATE	sucralfate	TABLET;ORAL	215576	ANDA	AvKARE	42291-936	42291-936-90	90 TABLET in 1 BOTTLE (42291-936-90)
SUCRALFATE	sucralfate	TABLET;ORAL	215576	ANDA	Amneal Pharmaceuticals NY LLC	60219-1656	60219-1656-1	100 TABLET in 1 BOTTLE (60219-1656-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	Apr 15, 2022	TE:	AB	RLD:	No

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