Assyro AI

Orange Book product · Generic (ANDA)

POSACONAZOLE

POSACONAZOLE

Generic (ANDA)ANDA 219057TE APRX ASPIRO

At a glance

Dec 23, 2024

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 23, 2024

    1 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

POSACONAZOLE

Strength

300MG/16.7ML (18MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 219057

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of POSACONAZOLE

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.