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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
January 11, 2021
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.

NuCare Pharmaceuticals, Inc.

NuCare Pharmaceuticals, Inc.

010632300

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
66267-596
Application Number
ANDA070848
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 11, 2021
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Code: XX73205DH5Class: ACTIBQuantity: 1 g in 1 1
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