Orange Book product
DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG
Orange Book ANDA 078992 · PLATINUM PHARMACEUTICALS · Prescription
Key facts
| Proprietary name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
|---|---|
| Active ingredients | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| Strength | 15MG |
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA078992 |
| Applicant holder | PLATINUM PHARMACEUTICALS |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 18, 2013 |
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.