Assyro AI

Orange Book product · Generic (ANDA)

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Generic (ANDA)ANDA 073209TE ABRX RISING

At a glance

Oct 31, 1991

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 31, 1991

    35 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Strength

EQ 5MG ANHYDROUS;50MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 073209

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of AMILORIDE HYDROCHLORIDE; 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.