Assyro AI

Orange Book product · Generic (ANDA)

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Generic (ANDA)ANDA 078905TE ABRX ZYDUS PHARMS USA INC

At a glance

Jan 31, 2011

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 31, 2011

    15 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Strength

2.5MG;250MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 078905

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GLIPIZIDE; 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.