Orange Book product
OXYCODONE AND ACETAMINOPHEN 300MG;10MG
Orange Book ANDA 040608 · MIKART LLC · Prescription
Key facts
| Proprietary name | OXYCODONE AND ACETAMINOPHEN |
|---|---|
| Active ingredients | ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE |
| Strength | 300MG;10MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA040608 |
| Applicant holder | MIKART LLC |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Dec 30, 2005 |
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.