Ovide
Ovide (malathion) Lotion, 0.5%
Approved
Approval ID
945f46fa-4b79-49fd-a890-477f251e2164
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2018
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Malathion
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-5293
Application NumberANDA091559
Product Classification
M
Marketing Category
C73584
G
Generic Name
Malathion
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 20, 2018
FDA Product Classification
INGREDIENTS (5)
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
MalathionActive
Quantity: 0.0005 g in 1 mL
Code: U5N7SU872W
Classification: ACTIB
terpineolInactive
Code: R53Q4ZWC99
Classification: IACT
pine needle oil (pinus sylvestris)Inactive
Code: 5EXL5H740Y
Classification: IACT
limonene, (+/-)-Inactive
Code: 9MC3I34447
Classification: IACT