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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-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

Summary for NDA: 021555

Tradename:
CHLORAPREP ONE-STEP SEPP
Applicant:
Becton Dickinson Co
Ingredient:
chlorhexidine gluconate; isopropyl alcohol
Patents:1
Formulation / Manufacturing:see details

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 54365-400-07 48 POUCH in 1 CARTON (54365-400-07) > 1 APPLICATOR in 1 POUCH > 1.75 mL in 1 APPLICATOR
CHLORAPREP ONE-STEP SEPP
chlorhexidine gluconate; isopropyl alcohol
SWAB;TOPICAL 021555 NDA CareFusion 213 LLC 54365-400 54365-400-06 60 POUCH in 1 CARTON (54365-400-06) > 1 APPLICATOR in 1 POUCH > 1 mL in 1 APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SWAB;TOPICALStrength2%;70% (0.67ML)
Approval Date:Oct 7, 2002TE:RLD:Yes
Patent:5,690,958Patent Expiration:Sep 30, 2016Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SWAB;TOPICALStrength2%;70% (1.75ML)
Approval Date:May 10, 2005TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:OTCDosage:SWAB;TOPICALStrength2%;70% (5.25ML)
Approval Date:Jun 10, 2009TE:RLD:Yes

Expired Orange Book Patents for NDA: 021555

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Becton Dickinson Co
CHLORAPREP ONE-STEP SEPP
chlorhexidine gluconate; isopropyl alcohol
SWAB;TOPICAL021555-001Oct 7, 20025,690,958► subscribe
Becton Dickinson Co
CHLORAPREP SINGLE SWABSTICK
chlorhexidine gluconate; isopropyl alcohol
SWAB;TOPICAL021555-002May 10, 20055,690,958► subscribe
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