Assyro AI

Orange Book product · Brand (NDA)

PREVANTICS MAXI SWABSTICK

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Brand (NDA)NDA 021524OTC PROF DSPLS
View CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL familyOpen on FDA Orange Book

At a glance

Jun 03, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 03, 2005

    21 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Strength

3.15%;70% (5.1ML)

Dosage form

SWAB

Route

TOPICAL

TE code

Not listed

Application

NDA 021524

Product number

003

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.

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