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. 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. Two suppliers are listed for this compound. Additional details are available on the malathion profile page.
The generic ingredient in OVIDE is malathion. There are three drug master file entries for this compound. Two 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 |
Medical Subject Heading (MeSH) Categories for 018613
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | LOTION;TOPICAL | Strength | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 2, 1982 | TE: | RLD: | Yes | |||||
| Patent: | See Plans and Pricing | Patent Expiration: | Feb 1, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PATIENTS INFECTED WITH PEDICULUS HUMANUS CAPITIS (HEAD LICE AND THEIR OVA) OF THE SCALP HAIR | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Aug 14, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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