Assyro AI

Orange Book product · Brand (NDA)

TRIVAGIZOLE 3

CLOTRIMAZOLE

Brand (NDA)NDA 021143OTC SUN PHARMA CANADA

At a glance

Apr 12, 2000

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 12, 2000

    26 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLOTRIMAZOLE

Strength

2%

Dosage form

CREAM

Route

VAGINAL

TE code

Not listed

Application

NDA 021143

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

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.