Orange Book product
CEREBYX EQ 50MG PHENYTOIN NA/ML
Orange Book NDA 020450 · PARKE DAVIS DIV WARNER LAMBERT CO · Prescription
Key facts
| Proprietary name | CEREBYX |
|---|---|
| Active ingredients | FOSPHENYTOIN SODIUM |
| Strength | EQ 50MG PHENYTOIN NA/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | NDA020450 |
| Applicant holder | PARKE DAVIS DIV WARNER LAMBERT CO |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Aug 5, 1996 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.