Assyro AI

Orange Book product · Generic (ANDA)

CLARITHROMYCIN

CLARITHROMYCIN

Generic (ANDA)ANDA 065136TE ABRX SANDOZ

At a glance

Aug 25, 2005

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 25, 2005

    21 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLARITHROMYCIN

Strength

500MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 065136

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CLARITHROMYCIN

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.