Assyro AI

Orange Book product · Generic (ANDA)

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE

Generic (ANDA)ANDA 091184TE ABRX ALKEM

At a glance

Nov 01, 2010

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 01, 2010

    15 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METFORMIN HYDROCHLORIDE

Strength

1GM

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 091184

Product number

003

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.