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Orange Book product · Generic (ANDA)

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE

Generic (ANDA)ANDA 203755TE AB3RX ACTAVIS LABS FL INC
View METFORMIN HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Aug 01, 2016

Approved

Generic (ANDA)

Application

AB3

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 01, 2016

    10 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

METFORMIN HYDROCHLORIDE

Strength

1GM

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

AB3

Application

ANDA 203755

Product number

002

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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