Orange Book product
HYDROCODONE BITARTRATE AND IBUPROFEN 5MG;200MG
Orange Book ANDA 077454 · ANI PHARMACEUTICALS INC · Discontinued
Key facts
| Proprietary name | HYDROCODONE BITARTRATE AND IBUPROFEN |
|---|---|
| Active ingredients | HYDROCODONE BITARTRATE, IBUPROFEN |
| Strength | 5MG;200MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA077454 |
| Applicant holder | ANI PHARMACEUTICALS INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jun 23, 2010 |
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.