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Generated: November 13, 2018

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Details for New Drug Application (NDA): 018300

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NDA 018300 describes HIBISTAT, which is a drug marketed by Molnlycke Hlth and is included in one NDA. It is available from one supplier. Additional details are available on the HIBISTAT profile page.

The generic ingredient in HIBISTAT is chlorhexidine gluconate. There are fifty-seven drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.
Summary for 018300
Tradename:HIBISTAT
Applicant:Molnlycke Hlth
Ingredient:chlorhexidine gluconate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018300
Suppliers and Packaging for NDA: 018300
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HIBISTAT chlorhexidine gluconate SOLUTION;TOPICAL 018300 NDA M?lnlycke Health Care US, LLC 0234-0587 0234-0587-17 50 PACKET in 1 CARTON (0234-0587-17) > 5 mL in 1 PACKET
HIBISTAT chlorhexidine gluconate SOLUTION;TOPICAL 018300 NDA M?lnlycke Health Care US, LLC 0234-0587 0234-0587-27 15 PACKET in 1 CARTON (0234-0587-27) > 5 mL in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength0.5%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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