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FDA Approval

LIDOCAINE

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

FDA Approval Summary

Company
Effective Date
October 8, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lidocaine(50 mg in 1 g)

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.

LIDOCAINE

Product Details

NDC Product Code
52959-993
Application Number
ANDA207810
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
October 8, 2018
LidocaineActive
Code: 98PI200987Class: ACTIBQuantity: 50 mg in 1 g
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