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Farmers Insurance
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Generated: July 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021524

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NDA 021524 describes PREVANTICS SWABSTICK, which is a drug marketed by Prof Dspls and is included in one NDA. It is available from one supplier. Additional details are available on the PREVANTICS SWABSTICK profile page.

The generic ingredient in PREVANTICS 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 021524
Tradename:PREVANTICS SWABSTICK
Applicant:Prof Dspls
Ingredient:chlorhexidine gluconate; isopropyl alcohol
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021524
Generic Entry Date for 021524*:
Constraining patent/regulatory exclusivity:
DRUG FACTS LABELING CHANGES UNDER THE DIRECTIONS HEADING TO REVISE THE STATED PREPARATION TIME OF A DRY SITE FROM 120 SECONDS SCRUBBING AND 90 SECONDS DRYING TO 30 SECONDS SCRUBBING AND 30 SECONDS DRYING
Dosage::
SWAB;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.

Suppliers and Packaging for NDA: 021524
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVANTICS MAXI SWABSTICK chlorhexidine gluconate; isopropyl alcohol SWAB;TOPICAL 021524 NDA Professional Disposables International, Inc. 10819-1080 N 10819-1080-2
PREVANTICS MAXI SWABSTICK chlorhexidine gluconate; isopropyl alcohol SWAB;TOPICAL 021524 NDA Professional Disposables International, Inc. 10819-1080 N 10819-1080-1

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SWAB;TOPICALStrength3.15%;70% (1ML)
Approval Date:Jun 3, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 14, 2021
Regulatory Exclusivity Use:DRUG FACTS LABELING CHANGES UNDER THE DIRECTIONS HEADING TO REVISE THE STATED PREPARATION TIME OF A DRY SITE FROM 120 SECONDS SCRUBBING AND 90 SECONDS DRYING TO 30 SECONDS SCRUBBING AND 30 SECONDS DRYING

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SWAB;TOPICALStrength3.15%;70% (1.6ML)
Approval Date:Jun 3, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 14, 2021
Regulatory Exclusivity Use:DRUG FACTS LABELING CHANGES UNDER THE DIRECTIONS HEADING TO REVISE THE STATED PREPARATION TIME OF A DRY SITE FROM 120 SECONDS SCRUBBING AND 90 SECONDS DRYING TO 30 SECONDS SCRUBBING AND 30 SECONDS DRYING

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:SWAB;TOPICALStrength3.15%;70% (5.1ML)
Approval Date:Jun 3, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 14, 2021
Regulatory Exclusivity Use:DRUG FACTS LABELING CHANGES UNDER THE DIRECTIONS HEADING TO REVISE THE STATED PREPARATION TIME OF A DRY SITE FROM 120 SECONDS SCRUBBING AND 90 SECONDS DRYING TO 30 SECONDS SCRUBBING AND 30 SECONDS DRYING

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Citi
Cipla
Fish and Richardson
Johnson and Johnson
Argus Health
QuintilesIMS
Cerilliant
McKesson

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