Drug application
BUTALBITAL AND ACETAMINOPHEN (ACETAMINOPHEN, BUTALBITAL)
Drugs@FDA ANDA 207313 · DR REDDYS LABS SA
Key facts
| Drug name | BUTALBITAL AND ACETAMINOPHEN |
|---|---|
| Active ingredients | ACETAMINOPHEN, BUTALBITAL |
| Application type | ANDA |
| Application number | 207313 |
| Company | DR REDDYS LABS SA |
| Dosage forms | CAPSULE, ORAL |
| Strength | 300MG;50MG |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Dec 27, 2017 |
At a glance
- 1–9 Submissions
- 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.