Details for New Drug Application (NDA): 021555

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NDA 021555 describes CHLORAPREP TRIPLE SWABSTICK, which is a drug marketed by Becton Dickinson Co and is included in one NDA. It is available from one supplier. Additional details are available on the CHLORAPREP TRIPLE SWABSTICK profile page.

The generic ingredient in CHLORAPREP TRIPLE SWABSTICK 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 021555

Tradename:	CHLORAPREP TRIPLE SWABSTICK
Applicant:	Becton Dickinson Co
Ingredient:	chlorhexidine gluconate; isopropyl alcohol
Patents:	0

Pharmacology for NDA: 021555

Physiological Effect	Decreased Cell Wall Integrity

Suppliers and Packaging for NDA: 021555

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORAPREP ONE-STEP SEPP	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555	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 SEPP	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555	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:	SWAB;TOPICAL			Strength	2%;70% (0.67ML)
Approval Date:	Oct 7, 2002	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	SWAB;TOPICAL			Strength	2%;70% (1.75ML)
Approval Date:	May 10, 2005	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	OTC	Dosage:	SWAB;TOPICAL			Strength	2%;70% (5.25ML)
Approval Date:	Jun 10, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 021555

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP ONE-STEP SEPP	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-001	Oct 7, 2002	⤷ Sign Up	⤷ Sign Up
Becton Dickinson Co	CHLORAPREP SINGLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-002	May 10, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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