Drug application
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE (EPINEPHRINE BITARTRATE, PRILOCAINE HYDROCHLORIDE)
Drugs@FDA ANDA 078959 · SEPTODONT INC
Key facts
| Drug name | PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE |
|---|---|
| Active ingredients | EPINEPHRINE BITARTRATE, PRILOCAINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 078959 |
| Company | SEPTODONT INC |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 0.005MG/ML;4% |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission status date | Aug 30, 2011 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
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.