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FDA Approval

CHLORHEXIDINE GLUCONATE

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

FDA Approval Summary

Company
Effective Date
August 27, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Chlorhexidine(1.2 mg in 1 mL)

Manufacturing Establishments1

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

H.J. Harkins Company, Inc.

H.J. Harkins Company, Inc.

147681894

Products1

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

CHLORHEXIDINE GLUCONATE

Product Details

NDC Product Code
76519-1067
Application Number
ANDA077789
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 27, 2018
Code: MOR84MUD8EClass: ACTIBQuantity: 1.2 mg in 1 mL
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