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FDA Approval

Lidocaine

CompanyMylan Pharmaceuticals Inc. (DUNS: 059295980)

Effective Date

November 28, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Lidocaine(140 mg in 1 1)

Products (1)

Lidocaine

NDC Product Code

0378-9055

Application Number

ANDA202346

Marketing Category

ANDA (C73584)

Route of Administration

CUTANEOUS

Effective Date

November 28, 2018

Ingredients

POLYISOBUTYLENE (1100000 MW)Inactive

Code: FLT10CH37XClass: IACT

POLYISOBUTYLENE (55000 MW)Inactive

Code: TQ77WR8A02Class: IACT

LidocaineActive

Code: 98PI200987Class: ACTIBQuantity: 140 mg in 1 1

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