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-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-seven suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.
The generic ingredient in EXIDINE 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 019127
| Tradename: | EXIDINE |
| Applicant: | Xttrium |
| Ingredient: | chlorhexidine gluconate |
| Patents: | 0 |
Pharmacology for NDA: 019127
| Physiological Effect | Decreased 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: | OTC | Dosage: | AEROSOL, METERED;TOPICAL | Strength | 4% | ||||
| Approval Date: | Dec 24, 1984 | TE: | RLD: | Yes | |||||
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