Assyro AI

Orange Book product · Generic (ANDA)

EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Generic (ANDA)ANDA 212198DISCN ZYDUS PHARMS

At a glance

Jul 07, 2022

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 07, 2022

    4 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Strength

5MG;1GM

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 212198

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of EMPAGLIFLOZIN; 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.