Assyro AI

Orange Book product · Brand (NDA)

ETHAMOLIN

ETHANOLAMINE OLEATE

Brand (NDA)NDA 019357RX QOL MEDCL

At a glance

Dec 22, 1988

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 22, 1988

    38 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHANOLAMINE OLEATE

Strength

50MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 019357

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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

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

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