Details for New Drug Application (NDA): 019422
✉ Email this page to a colleague
NDA 019422 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-four 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-four suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.
Summary for 019422
| Tradename: | EXIDINE |
| Applicant: | Xttrium |
| Ingredient: | chlorhexidine gluconate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019422
| Physiological Effect | Decreased 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: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 2% | ||||
| Approval Date: | Dec 17, 1985 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
