Orange Book product
BROMFENAC SODIUM EQ 0.09% ACID
Orange Book ANDA 210560 · ALEMBIC PHARMACEUTICALS LTD · Prescription
Key facts
| Proprietary name | BROMFENAC SODIUM |
|---|---|
| Active ingredients | BROMFENAC SODIUM |
| Strength | EQ 0.09% ACID |
| Dosage form | SOLUTION/DROPS |
| Route | OPHTHALMIC |
| Application | ANDA210560 |
| Applicant holder | ALEMBIC PHARMACEUTICALS LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AT2 |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Jun 21, 2019 |
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.