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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 one supplier. There are seven 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-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: 020832

Tradename:
CHLORAPREP ONE-STEP
Applicant:
Becton Dickinson Co
Ingredient:
chlorhexidine gluconate; isopropyl alcohol
Patents:9
Formulation / Manufacturing:see details

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 54365-400-07 48 POUCH in 1 CARTON (54365-400-07) > 1 APPLICATOR in 1 POUCH > 1.75 mL in 1 APPLICATOR
CHLORAPREP ONE-STEP
chlorhexidine gluconate; isopropyl alcohol
SPONGE;TOPICAL 020832 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:SPONGE;TOPICALStrength2%;70% (3ML)
Approval Date:Jul 14, 2000TE:RLD:Yes
Patent:5,690,958Patent Expiration:Sep 30, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,536,975Patent Expiration:Nov 10, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SPONGE;TOPICALStrength2%;70% (26ML)
Approval Date:May 3, 2005TE:RLD:Yes
Patent:5,690,958Patent Expiration:Sep 30, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020832

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Becton Dickinson Co
CHLORAPREP WITH TINT
chlorhexidine gluconate; isopropyl alcohol
SPONGE;TOPICAL020832-002May 3, 20055,690,958► subscribe
Becton Dickinson Co
CHLORAPREP ONE-STEP
chlorhexidine gluconate; isopropyl alcohol
SPONGE;TOPICAL020832-006Nov 21, 20065,690,958► subscribe
Becton Dickinson Co
CHLORAPREP ONE-STEP FREPP
chlorhexidine gluconate; isopropyl alcohol
SPONGE;TOPICAL020832-003Apr 26, 20025,690,958► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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