Orange Book product
PHENYTOIN SODIUM 50MG/ML
Orange Book ANDA 040573 · ACELLA PHARMACEUTICALS LLC · Prescription
Key facts
| Proprietary name | PHENYTOIN SODIUM |
|---|---|
| Active ingredients | PHENYTOIN SODIUM |
| Strength | 50MG/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA040573 |
| Applicant holder | ACELLA PHARMACEUTICALS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 13, 2006 |
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.