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Lindane

LINDANE SHAMPOO USP, 1%

Approved
Approval ID

ece04acb-bc22-46e4-8a97-e098bccca8e6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 13, 2011

Manufacturers
FDA

VersaPharm Incorporated

DUNS: 956741896

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 Code61748-400
Application NumberANDA087266
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lindane
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 17, 2009
FDA Product Classification

INGREDIENTS (6)

LINDANEActive
Quantity: 10 mg in 1 mL
Code: 59NEE7PCAB
Classification: ACTIB
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROLAMINE LAURYL SULFATEInactive
Code: E8458C1KAA
Classification: IACT
ACETONEInactive
Code: 1364PS73AF
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT

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Lindane - FDA Drug Approval Details