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Generated: September 20, 2018

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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
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 10819-1080-2 3000 POUCH in 1 CASE (10819-1080-2) > 1 mL in 1 POUCH
PREVANTICS MAXI SWABSTICK chlorhexidine gluconate; isopropyl alcohol SWAB;TOPICAL 021524 NDA Professional Disposables International, Inc. 10819-1080 10819-1080-1 100 POUCH in 1 BOX (10819-1080-1) > 1 mL in 1 POUCH

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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