Orange Book product
DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML
Orange Book ANDA 217797 · MICRO LABS LTD · Prescription
Key facts
| Proprietary name | DEXAMETHASONE SODIUM PHOSPHATE |
|---|---|
| Active ingredients | DEXAMETHASONE SODIUM PHOSPHATE |
| Strength | EQ 10MG PHOSPHATE/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA217797 |
| Applicant holder | MICRO LABS LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 27, 2024 |
At a glance
- 10–99 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.