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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 212913

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NDA 212913 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-seven 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-three suppliers are listed for this compound. Additional details are available on the sucralfate profile page.

Summary for 212913

Tradename:	SUCRALFATE
Applicant:	Mylan
Ingredient:	sucralfate
Patents:	0

Pharmacology for NDA: 212913

Medical Subject Heading (MeSH) Categories for 212913

Anti-Ulcer Agents

Suppliers and Packaging for NDA: 212913

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUCRALFATE	sucralfate	SUSPENSION;ORAL	212913	ANDA	Mylan Pharmaceuticals Inc.	0378-9205	0378-9205-35	420 mL in 1 BOTTLE, PLASTIC (0378-9205-35)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	1GM/10ML
Approval Date:	Sep 12, 2022	TE:	AB	RLD:	No

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