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FDA Approval

Sucralfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 2, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sucralfate(1 g in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sucralfate

Product Details

NDC Product Code
50090-6455
Application Number
ANDA074415
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 26, 2020
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
Code: XX73205DH5Class: ACTIBQuantity: 1 g in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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