Assyro AI

Orange Book product · Generic (ANDA)

ERYTHROMYCIN

ERYTHROMYCIN

Generic (ANDA)ANDA 210954TE ABRX AMNEAL PHARMS CO

At a glance

Jul 02, 2019

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 02, 2019

    7 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ERYTHROMYCIN

Strength

250MG

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 210954

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ERYTHROMYCIN

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.