Assyro AI

Orange Book product · Generic (ANDA)

ZIDOVUDINE

ZIDOVUDINE

Generic (ANDA)ANDA 091457DISCN AM REGENT

At a glance

May 06, 2010

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 06, 2010

    16 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ZIDOVUDINE

Strength

10MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 091457

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ZIDOVUDINE

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.