Assyro AI

Orange Book product · Generic (ANDA)

INGENOL MEBUTATE

INGENOL MEBUTATE

Generic (ANDA)ANDA 209019DISCN PADAGIS ISRAEL

At a glance

Jan 09, 2019

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 09, 2019

    7 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

INGENOL MEBUTATE

Strength

0.05%

Dosage form

GEL

Route

TOPICAL

TE code

Not listed

Application

ANDA 209019

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of INGENOL MEBUTATE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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