Orange Book product
IBUPROFEN 40MG/ML
Orange Book ANDA 079058 · TRIS PHARMA INC · Over the counter
Key facts
| Proprietary name | IBUPROFEN |
|---|---|
| Active ingredients | IBUPROFEN |
| Strength | 40MG/ML |
| Dosage form | SUSPENSION/DROPS |
| Route | ORAL |
| Application | ANDA079058 |
| Applicant holder | TRIS PHARMA INC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 31, 2009 |
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.