Assyro AI

Orange Book product · Brand (NDA)

BIAXIN

CLARITHROMYCIN

Brand (NDA)NDA 050698DISCN ABBVIE
View CLARITHROMYCIN familyOpen on FDA Orange Book

At a glance

Dec 23, 1993

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 23, 1993

    33 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

CLARITHROMYCIN

Strength

250MG/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 050698

Product number

002

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.

Book a Demo