Assyro AI

Orange Book product · Generic (ANDA)

VORICONAZOLE

VORICONAZOLE

Generic (ANDA)ANDA 220043RX HAINAN POLY PHARM

At a glance

Nov 14, 2025

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 14, 2025

    7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VORICONAZOLE

Strength

200MG/20ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

ANDA 220043

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of VORICONAZOLE

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.