Lindane
Lindane Shampoo, USP 1%Rx only
Approved
Approval ID
13ddf5e6-ac0e-41e6-b95d-d5bdd6b26fcd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2020
Manufacturers
FDA
Morton Grove Pharmaceuticals, Inc.
DUNS: 801897505
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lindane
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60432-834
Application NumberANDA088191
Product Classification
M
Marketing Category
C73584
G
Generic Name
lindane
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 30, 2020
FDA Product Classification
INGREDIENTS (6)
TRIETHANOLAMINE LAURYL SULFATEInactive
Code: E8458C1KAA
Classification: IACT
LINDANEActive
Quantity: 10 mg in 1 mL
Code: 59NEE7PCAB
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
ACETONEInactive
Code: 1364PS73AF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT