Assyro AI

Orange Book product · Generic (ANDA)

TELMISARTAN AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; TELMISARTAN

Generic (ANDA)ANDA 204169DISCN MACLEODS PHARMS LTD

At a glance

Nov 02, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 02, 2015

    10 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Strength

12.5MG;40MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 204169

Product number

001

Marketing status

DISCN

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.