Details for New Drug Application (NDA): 010417
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NDA 010417 describes XYLOCAINE 4% PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. Additional details are available on the XYLOCAINE 4% PRESERVATIVE FREE profile page.
The generic ingredient in XYLOCAINE 4% PRESERVATIVE FREE is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
The generic ingredient in XYLOCAINE 4% PRESERVATIVE FREE is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 010417
| Tradename: | XYLOCAINE 4% PRESERVATIVE FREE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 4% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;TOPICAL | Strength | 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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