Orange Book product
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 325MG;37.5MG
Orange Book ANDA 090485 · AMNEAL PHARMACEUTICALS · Prescription
Key facts
| Proprietary name | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
|---|---|
| Active ingredients | ACETAMINOPHEN, TRAMADOL HYDROCHLORIDE |
| Strength | 325MG;37.5MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA090485 |
| Applicant holder | AMNEAL PHARMACEUTICALS |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Dec 9, 2009 |
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.