Assyro AI

Orange Book product · Brand (NDA)

CHLORHEXIDINE GLUCONATE

CHLORHEXIDINE GLUCONATE

Brand (NDA)NDA 021669OTC SAGE PRODS

At a glance

Apr 25, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 25, 2005

    21 yr 6 mo ago

  2. Patent 7427574 expires

    Listed drug product patent expiration.

    Apr 25, 2026

    2 mo ago

  3. Today

  4. Patent 7935093 expires

    Listed drug product patent expiration.

    Oct 02, 2027

    in 1 yr 4 mo

Pharmaceutical detail

Active ingredient

CHLORHEXIDINE GLUCONATE

Strength

2%

Dosage form

CLOTH

Route

TOPICAL

TE code

Not listed

Application

NDA 021669

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 (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7427574Apr 25, 20262 mo ago
Product
7935093Oct 02, 2027in 1 yr 4 mo
ProductU-1022
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.