FDA Orange Book · active-ingredient family
Hydrocodone bitartrate; ibuprofen
Hydrocodone bitartrate; ibuprofen is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VICOPROFEN · NDA 020716
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VICOPROFENRLD | ABBVIE | NDA 020716 | — | Sep 23, 1997 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND IBUPROFEN | AUROLIFE PHARMA LLC | ANDA 204575 | AB | Jun 02, 2016 | |
| HYDROCODONE BITARTRATE AND IBUPROFEN×4 | SUN PHARM INDS INC | ANDA 091633 | — | May 28, 2013 | |
| HYDROCODONE BITARTRATE AND IBUPROFEN | ANI PHARMS | ANDA 077454 | — | Jun 23, 2010 | |
| HYDROCODONE×3 | STRIDES PHARMA | ANDA 077723 | — | Nov 06, 2006 | |
| HYDROCODONE BITARTRATE AND IBUPROFEN×4 | AMNEAL PHARMS NY | ANDA 076642 | — | Mar 18, 2004 | |
| HYDROCODONE BITARTRATE AND IBUPROFEN | ACTAVIS LABS FL INC | ANDA 076604 | AB | Dec 31, 2003 | |
| HYDROCODONE BITARTRATE AND IBUPROFEN | TEVA | ANDA 076023 | — | Apr 11, 2003 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Hydrocodone bitartrate; ibuprofen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
