Orange Book product
FENOPROFEN CALCIUM EQ 300MG BASE
Orange Book ANDA 215548 · MISEMER PHARMACEUTICALS INC · Prescription
Key facts
| Proprietary name | FENOPROFEN CALCIUM |
|---|---|
| Active ingredients | FENOPROFEN CALCIUM |
| Strength | EQ 300MG BASE |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA215548 |
| Applicant holder | MISEMER PHARMACEUTICALS INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | May 16, 2023 |
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.