Orange Book product
OXYCODONE AND ACETAMINOPHEN 325MG;10MG
Orange Book ANDA 201447 · ACTAVIS ELIZABETH LLC · Prescription
Key facts
| Proprietary name | OXYCODONE AND ACETAMINOPHEN |
|---|---|
| Active ingredients | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE |
| Strength | 325MG;10MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA201447 |
| Applicant holder | ACTAVIS ELIZABETH LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Apr 12, 2013 |
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.