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Orange Book product · Generic (ANDA)

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE

Generic (ANDA)ANDA 215008TE ABRX ANNORA PHARMA
View METFORMIN HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Mar 13, 2025

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 13, 2025

    1 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METFORMIN HYDROCHLORIDE

Strength

500MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

AB

Application

ANDA 215008

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

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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