Details for New Drug Application (NDA): 074522
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NDA 074522 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 twenty-nine 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 074522
| Tradename: | CHLORHEXIDINE GLUCONATE |
| Applicant: | Pharm Assoc |
| Ingredient: | chlorhexidine gluconate |
| Patents: | 0 |
Pharmacology for NDA: 074522
| Physiological Effect | Decreased Cell Wall Integrity |
Medical Subject Heading (MeSH) Categories for 074522
Suppliers and Packaging for NDA: 074522
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORHEXIDINE GLUCONATE | chlorhexidine gluconate | SOLUTION;DENTAL | 074522 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0893 | 0121-0893-00 | 10 TRAY in 1 CASE (0121-0893-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15) |
| CHLORHEXIDINE GLUCONATE | chlorhexidine gluconate | SOLUTION;DENTAL | 074522 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0893 | 0121-0893-16 | 473 mL in 1 BOTTLE (0121-0893-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;DENTAL | Strength | 0.12% | ||||
| Approval Date: | Dec 15, 1995 | TE: | AT | RLD: | No | ||||
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