Details for New Drug Application (NDA): 021381
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NDA 021381 describes XYLOCAINE DENTAL WITH EPINEPHRINE, which is a drug marketed by Dentsply Pharm and is included in one NDA. Additional details are available on the XYLOCAINE DENTAL WITH EPINEPHRINE profile page.
The generic ingredient in XYLOCAINE DENTAL WITH EPINEPHRINE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
The generic ingredient in XYLOCAINE DENTAL WITH EPINEPHRINE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 021381
| Tradename: | XYLOCAINE DENTAL WITH EPINEPHRINE |
| Applicant: | Dentsply Pharm |
| Ingredient: | epinephrine; lidocaine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | No | |||||
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