Assyro AI

Orange Book product · Generic (ANDA)

SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Generic (ANDA)ANDA 088054DISCN PUREPAC PHARM
View HYDROCHLOROTHIAZIDE; SPIRONOLACTONE familyOpen on FDA Orange Book

At a glance

Aug 18, 1983

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 18, 1983

    43 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Strength

25MG;25MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 088054

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; SPIRONOLACTONE

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.

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