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Last Updated: May 4, 2024

Details for New Drug Application (NDA): 215705

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NDA 215705 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 215705

Tradename:	SUCRALFATE
Applicant:	Zydus Lifesciences
Ingredient:	sucralfate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 215705

Medical Subject Heading (MeSH) Categories for 215705

Anti-Ulcer Agents

Suppliers and Packaging for NDA: 215705

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUCRALFATE	sucralfate	TABLET;ORAL	215705	ANDA	REMEDYREPACK INC.	70518-3959	70518-3959-0	30 TABLET in 1 BLISTER PACK (70518-3959-0)
SUCRALFATE	sucralfate	TABLET;ORAL	215705	ANDA	Zydus Lifesciences Limited	70771-1833	70771-1833-1	100 TABLET in 1 BOTTLE (70771-1833-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	May 3, 2023	TE:	AB	RLD:	No

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