Orange Book product
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 500MG;50MG;40MG
Orange Book ANDA 040336 · HIKMA PHARMACEUTICALS LLC · Discontinued
Key facts
| Proprietary name | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
|---|---|
| Active ingredients | ACETAMINOPHEN, BUTALBITAL, CAFFEINE |
| Strength | 500MG;50MG;40MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA040336 |
| Applicant holder | HIKMA PHARMACEUTICALS LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 18, 1999 |
At a glance
- None Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.