Orange Book product
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE 325MG;50MG;40MG;30MG
Orange Book ANDA 074951 · JEROME STEVENS PHARMACEUTICALS INC · Prescription
Key facts
| Proprietary name | BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE |
|---|---|
| Active ingredients | ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE |
| Strength | 325MG;50MG;40MG;30MG |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA074951 |
| Applicant holder | JEROME STEVENS PHARMACEUTICALS INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Aug 31, 1998 |
At a glance
- 1–9 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.