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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 019127


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NDA 019127 describes EXIDINE, which is a drug marketed by Xttrium and is included in four NDAs. It is available from twenty-five suppliers. Additional details are available on the EXIDINE profile page.

The generic ingredient in EXIDINE is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.
Summary for 019127
Tradename:EXIDINE
Applicant:Xttrium
Ingredient:chlorhexidine gluconate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019127
Physiological EffectDecreased Cell Wall Integrity
Medical Subject Heading (MeSH) Categories for 019127
Suppliers and Packaging for NDA: 019127
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXIDINE chlorhexidine gluconate AEROSOL, METERED;TOPICAL 019127 NDA Xttrium Laboratories, Inc. 0116-0505 0116-0505-01 946 mL in 1 BOTTLE (0116-0505-01)
EXIDINE chlorhexidine gluconate AEROSOL, METERED;TOPICAL 019127 NDA Xttrium Laboratories, Inc. 0116-0505 0116-0505-02 946 mL in 1 BOTTLE (0116-0505-02)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, METERED;TOPICALStrength4%
Approval Date:Dec 24, 1984TE:RLD:Yes

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