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Last Updated: July 8, 2020

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Details for New Drug Application (NDA): 019125

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NDA 019125 describes EXIDINE, which is a drug marketed by Xttrium and is included in four NDAs. It is available from twenty-three 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-five suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.
Summary for 019125
Ingredient:chlorhexidine gluconate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019125
Physiological EffectDecreased Cell Wall Integrity
Medical Subject Heading (MeSH) Categories for 019125
Suppliers and Packaging for NDA: 019125
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXIDINE chlorhexidine gluconate SOLUTION;TOPICAL 019125 NDA Xttrium Laboratories, Inc. 0116-0115 0116-0115-37 237 mL in 1 BOTTLE, PLASTIC (0116-0115-37)
EXIDINE chlorhexidine gluconate SOLUTION;TOPICAL 019125 NDA Xttrium Laboratories, Inc. 0116-0137 0116-0137-34 237 mL in 1 BOTTLE, PLASTIC (0116-0137-34)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength4%
Approval Date:Dec 24, 1984TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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