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FDA NDA · NDA018613

OVIDE

Sponsor: TARO

APPLICATION
NDA018613
TYPE
NDA
ORIGINAL APPROVAL
1982-08-02
LATEST ACTION
2011-12-09
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

OVIDE · ReferenceDiscontinued
MALATHION 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL

Approval history

2011-12-09Labeling · Supplement 17 · standard — Letter ↗AP
2003-04-04Labeling · Supplement 11 · standard — Label ↗AP
1999-04-30Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
1999-04-30Labeling · Supplement 10 · standard — Review ↗AP
1989-07-14Labeling · Supplement 7AP
1988-12-02Labeling · Supplement 1AP
1987-05-13Manufacturing (CMC) · Supplement 4 · standardAP
1985-03-27Manufacturing (CMC) · Supplement 3 · standardAP
1982-08-02Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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