Assyro AI

Orange Book product · Generic (ANDA)

DANAZOL

DANAZOL

Generic (ANDA)ANDA 074582TE ABRX BARR

At a glance

May 29, 1998

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 29, 1998

    28 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DANAZOL

Strength

50MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 074582

Product number

003

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DANAZOL

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.