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Orange Book product · Generic (ANDA)

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Generic (ANDA)ANDA 200823TE ABRX AUROBINDO PHARMA LTD

At a glance

Feb 13, 2013

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 13, 2013

    13 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Strength

500MG;EQ 15MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 200823

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

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.