Assyro AI

Orange Book product · Generic (ANDA)

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Generic (ANDA)ANDA 077337DISCN TEVA

At a glance

May 07, 2014

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 07, 2014

    12 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Strength

1GM;EQ 4MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 077337

Product number

004

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

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.