Details for New Drug Application (NDA): 021496
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NDA 021496 describes DUOCAINE, which is a drug marketed by Amphastar Pharms Inc and is included in one NDA. Additional details are available on the DUOCAINE profile page.
The generic ingredient in DUOCAINE is bupivacaine hydrochloride; lidocaine hydrochloride. There are twelve drug master file entries for this compound. Additional details are available on the bupivacaine hydrochloride; lidocaine hydrochloride profile page.
The generic ingredient in DUOCAINE is bupivacaine hydrochloride; lidocaine hydrochloride. There are twelve drug master file entries for this compound. Additional details are available on the bupivacaine hydrochloride; lidocaine hydrochloride profile page.
Summary for 021496
| Tradename: | DUOCAINE |
| Applicant: | Amphastar Pharms Inc |
| Ingredient: | bupivacaine hydrochloride; lidocaine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML) | ||||
| Approval Date: | May 23, 2003 | TE: | RLD: | No | |||||
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