Assyro AI

Orange Book product · Generic (ANDA)

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

Generic (ANDA)ANDA 088587DISCN ROXANE

At a glance

Jul 02, 1984

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 02, 1984

    42 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE

Strength

50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

ANDA 088587

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HYDROCHLOROTHIAZIDE

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.