Details for New Drug Application (NDA): 077250
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NDA 077250 describes VIVACAINE, which is a drug marketed by Septodont and is included in one NDA. It is available from one supplier. Additional details are available on the VIVACAINE profile page.
The generic ingredient in VIVACAINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
The generic ingredient in VIVACAINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 077250
| Tradename: | VIVACAINE |
| Applicant: | Septodont |
| Ingredient: | bupivacaine hydrochloride; epinephrine bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 077250
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 077250
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIVACAINE | bupivacaine hydrochloride; epinephrine bitartrate | INJECTABLE;INJECTION | 077250 | ANDA | Septodont, Inc. | 0362-0557 | 0362-0557-05 | 50 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE |
| VIVACAINE | bupivacaine hydrochloride; epinephrine bitartrate | INJECTABLE;INJECTION | 077250 | ANDA | Septodont, Inc. | 0362-9011 | 0362-9011-50 | 50 CARTRIDGE in 1 CARTON (0362-9011-50) / 1.8 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5%;0.0091MG/ML | ||||
| Approval Date: | Sep 27, 2006 | TE: | RLD: | No | |||||
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