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Orange Book product · Generic (ANDA)

AMOXICILLIN AND CLAVULANATE POTASSIUM

AMOXICILLIN; CLAVULANATE POTASSIUM

Generic (ANDA)ANDA 065161DISCN SUN PHARM INDS LTD

At a glance

Dec 03, 2003

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 03, 2003

    22 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Strength

200MG;EQ 28.5MG BASE

Dosage form

TABLET, CHEWABLE

Route

ORAL

TE code

Not listed

Application

ANDA 065161

Product number

001

Marketing status

DISCN

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

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