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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
November 11, 2022
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.

Advanced Rx Pharmacy of Tennessee, LLC

Advanced Rx Pharmacy of Tennessee, LLC

117023142

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
80425-0188
Application Number
ANDA074415
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 11, 2022
Code: XX73205DH5Class: ACTIBQuantity: 1 g in 1 1
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