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Orange Book product · Generic (ANDA)

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Generic (ANDA)ANDA 078827DISCN NATCO PHARMA USA

At a glance

Oct 26, 2016

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 26, 2016

    9 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Strength

12.5MG;20MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 078827

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; OLMESARTAN MEDOXOMIL

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.