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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 017768


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NDA 017768 describes HIBICLENS, which is a drug marketed by Molnlycke Hlth and is included in two NDAs. It is available from three suppliers. Additional details are available on the HIBICLENS profile page.

The generic ingredient in HIBICLENS is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.
Summary for 017768
Tradename:HIBICLENS
Applicant:Molnlycke Hlth
Ingredient:chlorhexidine gluconate
Patents:0
Pharmacology for NDA: 017768
Physiological EffectDecreased Cell Wall Integrity
Medical Subject Heading (MeSH) Categories for 017768
Suppliers and Packaging for NDA: 017768
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HIBICLENS chlorhexidine gluconate SOLUTION;TOPICAL 017768 NDA Xttrium Laboratories, Inc. 0116-0575 0116-0575-04 118 mL in 1 BOTTLE, PLASTIC (0116-0575-04)
HIBICLENS chlorhexidine gluconate SOLUTION;TOPICAL 017768 NDA Xttrium Laboratories, Inc. 0116-0575 0116-0575-08 236 mL in 1 BOTTLE, PLASTIC (0116-0575-08)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength4%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 017768

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Molnlycke Hlth HIBICLENS chlorhexidine gluconate SOLUTION;TOPICAL 017768-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Molnlycke Hlth HIBICLENS chlorhexidine gluconate SOLUTION;TOPICAL 017768-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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