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LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%

Approved
Approval ID

6f79a974-6d8f-480a-93be-1b4bea1cf603

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 28, 2023

Manufacturers
FDA

Wockhardt USA LLC.

DUNS: 170508365

Products 1

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

lidocaine hydrochloride

PRODUCT DETAILS

NDC Product Code64679-465
Application NumberANDA087881
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMarch 28, 2023
Generic Namelidocaine hydrochloride

INGREDIENTS (5)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR

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LIDOCAINE HYDROCHLORIDE - FDA Drug Approval Details