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Last Updated: December 5, 2020

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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-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 021524
Generic Entry Opportunity Date for 021524
Generic Entry Date for 021524*:
Constraining patent/regulatory exclusivity:
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 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:

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:

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:

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