Orange Book product · Brand (NDA)

CHLORAPREP ONE-STEP

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Brand (NDA)NDA 020832OTC BECTON DICKINSON CO

View CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL family Open on FDA Orange Book

At a glance

Jul 14, 2000

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jul 14, 2000
26 yr 4 mo ago
Today

Pharmaceutical detail

Active ingredient

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Strength

2%;70% (3ML)

Dosage form

SPONGE

Route

TOPICAL

TE code

Not listed

Application

NDA 020832

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.

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