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FDA Approval

Sucralfate

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

FDA Approval Summary

Effective Date
June 8, 2010
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.

State of Florida DOH Central Pharmacy

State of Florida DOH Central Pharmacy

829348114

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
53808-0593
Application Number
NDA018333
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
June 8, 2010
Code: XX73205DH5Class: ACTIBQuantity: 1 g in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
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