FDA Product

Lindane

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Lindane

FDA Product Code

60432-834

Regulatory Information

NDC Product Code

60432-834

Application Number

ANDA088191

Marketing Category

C73584

Effective Date

December 30, 2020

Territorial Authority

USA

FDA Title

Lindane Shampoo, USP 1%Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

7

Company Information

ManufacturerMorton Grove Pharmaceuticals, Inc.

DUNS Number

801897505

Active Ingredients

TRIETHANOLAMINE LAURYL SULFATE

Code: E8458C1KAA

Class Code: IACT

Quantity: 10 mg in 1 mL

Code: 59NEE7PCAB

Class Code: ACTIB

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

POLYSORBATE 60

Code: CAL22UVI4M

Class Code: IACT

ACETONE

Code: 1364PS73AF

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

LINDANE

Code: 59NEE7PCAB

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