Drug application
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (ACETAMINOPHEN, BUTALBITAL, CAFFEINE)
Drugs@FDA ANDA 215135 · HIKMA PHARMS
Key facts
| Drug name | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
|---|---|
| Active ingredients | ACETAMINOPHEN, BUTALBITAL, CAFFEINE |
| Application type | ANDA |
| Application number | 215135 |
| Company | HIKMA PHARMS |
| Dosage forms | CAPSULE, ORAL |
| Strength | 300MG;50MG;40MG |
| Marketing status | Discontinued |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Mar 25, 2022 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 10–99 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.