Assyro AI

Orange Book product · Generic (ANDA)

CLARITHROMYCIN

CLARITHROMYCIN

Generic (ANDA)ANDA 065210DISCN RANBAXY

At a glance

Jan 26, 2005

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 26, 2005

    21 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLARITHROMYCIN

Strength

1GM

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 065210

Product number

001

Marketing status

DISCN

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.