Assyro AI

Orange Book product · Brand (NDA)

VANDAZOLE

METRONIDAZOLE

Brand (NDA)NDA 021806TE BXRX TEVA PHARMS

At a glance

May 20, 2005

Approved

Brand (NDA)

Application

BX

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 20, 2005

    21 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METRONIDAZOLE

Strength

0.75%

Dosage form

GEL

Route

VAGINAL

TE code

BX

Application

NDA 021806

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.