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FDA Approval

Cephalexin

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

FDA Approval Summary

Effective Date
January 18, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cephalexin(500 mg 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.

Cephalexin

Product Details

NDC Product Code
80425-0005
Application Number
ANDA065229
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 18, 2024
Code: OBN7UDS42YClass: ACTIMQuantity: 500 mg in 1 1
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