Orange Book product
BUTALBITAL AND ACETAMINOPHEN 325MG;50MG
Orange Book ANDA 087550 · WATSON LABORATORIES INC · Discontinued
Key facts
| Proprietary name | BUTALBITAL AND ACETAMINOPHEN |
|---|---|
| Active ingredients | ACETAMINOPHEN, BUTALBITAL |
| Strength | 325MG;50MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA087550 |
| Applicant holder | WATSON LABORATORIES INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Oct 19, 1984 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.