Orange Book product
DILANTIN 30MG EXTENDED
Orange Book ANDA 084349 · VIATRIS SPECIALTY LLC · Prescription
Key facts
| Proprietary name | DILANTIN |
|---|---|
| Active ingredients | PHENYTOIN SODIUM |
| Strength | 30MG EXTENDED |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA084349 |
| Applicant holder | VIATRIS SPECIALTY LLC |
| Marketing status | Prescription |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Jan 1, 1982 |
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.