Details for New Drug Application (NDA): 077789
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NDA 077789 describes CHLORHEXIDINE GLUCONATE, which is a drug marketed by Sage Prods, Bajaj, Chartwell Rx, Lyne, Pharm Assoc, Sciegen Pharms Inc, Xttrium, Becton Dickinson, and Kendall Il, and is included in ten NDAs. It is available from thirty suppliers. There are four patents protecting this drug. Additional details are available on the CHLORHEXIDINE GLUCONATE profile page.
The generic ingredient in CHLORHEXIDINE GLUCONATE 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 CHLORHEXIDINE GLUCONATE 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 077789
| Tradename: | CHLORHEXIDINE GLUCONATE |
| Applicant: | Xttrium |
| Ingredient: | chlorhexidine gluconate |
| Patents: | 0 |
Pharmacology for NDA: 077789
| Physiological Effect | Decreased Cell Wall Integrity |
Medical Subject Heading (MeSH) Categories for 077789
Suppliers and Packaging for NDA: 077789
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORHEXIDINE GLUCONATE | chlorhexidine gluconate | SOLUTION;DENTAL | 077789 | ANDA | Xttrium Laboratories, Inc. | 0116-0003 | 0116-0003-15 | 15 mL in 1 BOTTLE (0116-0003-15) |
| CHLORHEXIDINE GLUCONATE | chlorhexidine gluconate | SOLUTION;DENTAL | 077789 | ANDA | Xttrium Laboratories, Inc. | 0116-0101 | 0116-0101-01 | 473 mL in 1 BOTTLE (0116-0101-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;DENTAL | Strength | 0.12% | ||||
| Approval Date: | Jun 18, 2009 | TE: | AT | RLD: | No | ||||
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