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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts

Last Updated: June 10, 2023

Details for New Drug Application (NDA): 019422

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NDA 019422 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-three suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.
Summary for 019422
Ingredient:chlorhexidine gluconate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019422
Physiological EffectDecreased Cell Wall Integrity
Medical Subject Heading (MeSH) Categories for 019422
Suppliers and Packaging for NDA: 019422
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXIDINE chlorhexidine gluconate SOLUTION;TOPICAL 019422 NDA Xttrium Laboratories, Inc. 0116-0038 0116-0038-03 118 mL in 1 BOTTLE (0116-0038-03)
EXIDINE chlorhexidine gluconate SOLUTION;TOPICAL 019422 NDA Xttrium Laboratories, Inc. 0116-0113 0116-0113-04 118 mL in 1 BOTTLE, PLASTIC (0116-0113-04)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength2%
Approval Date:Dec 17, 1985TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Boehringer Ingelheim

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