Drug application
DUOCAINE (BUPIVACAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE)
Drugs@FDA NDA 021496 · AMPHASTAR PHARMS INC
Key facts
| Drug name | DUOCAINE |
|---|---|
| Active ingredients | BUPIVACAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 021496 |
| Company | AMPHASTAR PHARMS INC |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | EQ 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML) |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | May 23, 2003 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: