Details for New Drug Application (NDA): 020832

NDA 020832 describes CHLORAPREP WITH TINT, which is a drug marketed by Becton Dickinson Co and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the CHLORAPREP WITH TINT profile page.

The generic ingredient in CHLORAPREP WITH TINT is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

Summary for 020832

Tradename:	CHLORAPREP WITH TINT
Applicant:	Becton Dickinson Co
Ingredient:	chlorhexidine gluconate; isopropyl alcohol
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 020832

Dosage:

SPONGE;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 020832

Physiological Effect

Decreased Cell Wall Integrity

Suppliers and Packaging for NDA: 020832

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832	NDA	CareFusion 213, LLC	54365-400	54365-400-31	60 POUCH in 1 CARTON (54365-400-31) / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR
CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832	NDA	CareFusion 213, LLC	54365-400	54365-400-30	20 POUCH in 1 CARTON (54365-400-30) / 1 APPLICATOR in 1 POUCH / 1.5 mL in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SPONGE;TOPICAL			Strength	2%;70% (3ML)
Approval Date:	Jul 14, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	SPONGE;TOPICAL			Strength	2%;70% (26ML)
Approval Date:	May 3, 2005	TE:		RLD:	Yes
Patent:		Patent Expiration:	Apr 25, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY

Profile for product number 003

Active Rx/OTC/Discontinued:	OTC	Dosage:	SPONGE;TOPICAL			Strength	2%;70% (1.5ML)
Approval Date:	Apr 26, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 020832

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-004	Aug 20, 2003
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005

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