Assyro AI

Orange Book product · Generic (ANDA)

OXANDROLONE

OXANDROLONE

Generic (ANDA)ANDA 078033DISCN UPSHER SMITH LABS

At a glance

Mar 22, 2007

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 22, 2007

    19 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OXANDROLONE

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 078033

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of OXANDROLONE

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.