Assyro AI

Orange Book product · Brand (NDA)

OVIDE

MALATHION

Brand (NDA)NDA 018613DISCN TARO

At a glance

Aug 02, 1982

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 02, 1982

    44 yr 6 mo ago

  2. Today

  3. Patent 7977324 expires

    Listed drug product patent expiration.

    Aug 14, 2026

    in 2 mo

  4. Patent 7560445 expires

    Listed drug substance patent expiration.

    Feb 01, 2027

    in 8 mo

Pharmaceutical detail

Active ingredient

MALATHION

Strength

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

LOTION

Route

TOPICAL

TE code

Not listed

Application

NDA 018613

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7977324Aug 14, 2026in 2 mo
Product
7560445Feb 01, 2027in 8 mo
SubstanceProductU-986
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.