Orange Book product
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL
Orange Book ANDA 202691 · HIKMA FARMACEUTICA PORTUGAL SA · Prescription
Key facts
| Proprietary name | METHYLPREDNISOLONE SODIUM SUCCINATE |
|---|---|
| Active ingredients | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Strength | EQ 1GM BASE/VIAL |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA202691 |
| Applicant holder | HIKMA FARMACEUTICA PORTUGAL SA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 16, 2016 |
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.