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.

NDC Product Code51672-5293

Application NumberANDA091559

Marketing CategoryC73584

Route of AdministrationTOPICAL

Effective DateJuly 20, 2018

Generic NameMalathion

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