Orange Book product
ACAMPROSATE CALCIUM 333MG
Orange Book ANDA 219904 · BIONPHARMA INC · Prescription
Key facts
| Proprietary name | ACAMPROSATE CALCIUM |
|---|---|
| Active ingredients | ACAMPROSATE CALCIUM |
| Strength | 333MG |
| Dosage form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Application | ANDA219904 |
| Applicant holder | BIONPHARMA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 18, 2025 |
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.