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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 NDA: 021524

Tradename:
PREVANTICS MAXI SWABSTICK
Applicant:
Prof Dspls
Ingredient:
chlorhexidine gluconate; isopropyl alcohol
Patents:1
Formulation / Manufacturing:see details

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 10819-1080-1 100 POUCH in 1 BOX (10819-1080-1) > 1 mL in 1 POUCH
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

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SWAB;TOPICALStrength3.15%;70% (1ML)
Approval Date:Jun 3, 2005TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SWAB;TOPICALStrength3.15%;70% (1.6ML)
Approval Date:Jun 3, 2005TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:OTCDosage:SWAB;TOPICALStrength3.15%;70% (5.1ML)
Approval Date:Jun 3, 2005TE:RLD:Yes
Patent:D468424Patent Expiration:Jan 7, 2017Product Flag?Substance Flag?Delist Request?


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