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Generated: November 17, 2018

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Details for New Drug Application (NDA): 018613

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NDA 018613 describes OVIDE, which is a drug marketed by Taro Pharm Inds Ltd and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OVIDE profile page.

The generic ingredient in OVIDE is malathion. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the malathion profile page.
Summary for 018613
Tradename:OVIDE
Applicant:Taro Pharm Inds Ltd
Ingredient:malathion
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 018613
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 018613
Suppliers and Packaging for NDA: 018613
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OVIDE malathion LOTION;TOPICAL 018613 NDA TARO PHARMACEUTICALS USA, INC. 51672-5276 51672-5276-4 1 BOTTLE in 1 CARTON (51672-5276-4) > 59 mL in 1 BOTTLE
OVIDE malathion LOTION;TOPICAL 018613 NDA TARO PHARMACEUTICALS U.S.A., INC. 51672-5277 51672-5277-4 1 BOTTLE in 1 CARTON (51672-5277-4) > 59 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.5%
Approval Date:Aug 2, 1982TE:ATRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 1, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS INFECTED WITH PEDICULUS HUMANUS CAPITIS (HEAD LICE AND THEIR OVA) OF THE SCALP HAIR
Patent:➤ Try a Free TrialPatent Expiration:Aug 14, 2026Product Flag?YSubstance Flag?Delist Request?

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