Assyro AI

Orange Book product · Generic (ANDA)

AMOXICILLIN AND CLAVULANATE POTASSIUM

AMOXICILLIN; CLAVULANATE POTASSIUM

Generic (ANDA)ANDA 065191TE ABRX HIKMA PHARMS

At a glance

Jan 25, 2005

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 25, 2005

    21 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

AB

Application

ANDA 065191

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMOXICILLIN; CLAVULANATE POTASSIUM

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.