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Orange Book product · Generic (ANDA)

AMOXICILLIN AND CLAVULANATE POTASSIUM

AMOXICILLIN; CLAVULANATE POTASSIUM

Generic (ANDA)ANDA 210374TE ABRX DEVA HOLDING AS

At a glance

Nov 29, 2023

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 29, 2023

    2 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Strength

250MG/5ML;EQ 62.5MG BASE/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

AB

Application

ANDA 210374

Product number

001

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.