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Lidocaine

LIDOCAINE OINTMENT USP, 5%

Approved
Approval ID

c66b3509-c670-4124-86ac-da313958aabd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 9, 2011

Manufacturers
FDA

Novocol Inc.

DUNS: 023384621

Products 1

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

Lidocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57539-0221
Application NumberANDA040911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 9, 2011
FDA Product Classification

INGREDIENTS (3)

Polyethylene Glycol 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
LidocaineActive
Quantity: 5 g in 100 g
Code: 98PI200987
Classification: ACTIB
Polyethylene Glycol 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT

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Lidocaine - FDA Drug Approval Details