Assyro AI

Orange Book product · Brand (NDA)

CESAMET

NABILONE

Brand (NDA)NDA 018677DISCN BAUSCH

At a glance

Dec 26, 1985

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 26, 1985

    41 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NABILONE

Strength

1MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 018677

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

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.