Assyro AI

Orange Book product · Brand (NDA)

BENZACLIN

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Brand (NDA)NDA 050756DISCN BAUSCH

At a glance

Apr 20, 2007

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 20, 2007

    19 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Strength

5%;EQ 1% BASE

Dosage form

GEL

Route

TOPICAL

TE code

Not listed

Application

NDA 050756

Product number

002

Marketing status

DISCN

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.