Assyro AI

Orange Book product · Generic (ANDA)

TELMISARTAN AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; TELMISARTAN

Generic (ANDA)ANDA 202544TE ABRX GLENMARK PHARMS LTD

At a glance

Mar 04, 2019

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 04, 2019

    7 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Strength

12.5MG;40MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 202544

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HYDROCHLOROTHIAZIDE; TELMISARTAN

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.