Orange Book product
HYDROCODONE BITARTRATE AND IBUPROFEN 7.5MG;200MG
Orange Book ANDA 076604 · ACTAVIS LABORATORIES FL INC · Prescription
Key facts
| Proprietary name | HYDROCODONE BITARTRATE AND IBUPROFEN |
|---|---|
| Active ingredients | HYDROCODONE BITARTRATE, IBUPROFEN |
| Strength | 7.5MG;200MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA076604 |
| Applicant holder | ACTAVIS LABORATORIES FL INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 31, 2003 |
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.