Details for New Drug Application (NDA): 020832

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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 are two patents 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:	2

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	54365-400-05	1 APPLICATOR in 1 POUCH (54365-400-05) / 26 mL in 1 APPLICATOR
CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832	NDA	CareFusion 213 LLC	54365-400	54365-400-13	1 APPLICATOR in 1 POUCH (54365-400-13) / 26 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:	⤷ Sign Up	Patent Expiration:	Jan 31, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	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

Expired US Patents for NDA 020832

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-005	Apr 3, 2006	⤷ Sign Up	⤷ Sign Up
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	⤷ Sign Up	⤷ Sign Up
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	⤷ Sign Up	⤷ Sign Up
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-005	Apr 3, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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