Assyro AI

Orange Book product · Brand (NDA)

EXIDINE

CHLORHEXIDINE GLUCONATE

Brand (NDA)NDA 019127OTC XTTRIUM

At a glance

Dec 24, 1984

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 24, 1984

    42 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CHLORHEXIDINE GLUCONATE

Strength

4%

Dosage form

AEROSOL, METERED

Route

TOPICAL

TE code

Not listed

Application

NDA 019127

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this 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.