Orange Book product
DICLOFENAC SODIUM 50MG
Orange Book ANDA 090066 · UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD · Prescription
Key facts
| Proprietary name | DICLOFENAC SODIUM |
|---|---|
| Active ingredients | DICLOFENAC SODIUM |
| Strength | 50MG |
| Dosage form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Application | ANDA090066 |
| Applicant holder | UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Dec 1, 2010 |
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.