FDA Orange Book · active-ingredient family
Hydrocodone bitartrate; pseudoephedrine hydrochloride
Hydrocodone bitartrate; pseudoephedrine hydrochloride is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:REZIRA · NDA 022442
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REZIRARLD | PERSION | NDA 022442 | — | Jun 08, 2011 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | SCIEGEN PHARMS | ANDA 206661 | — | Jan 23, 2019 | |
| HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | MAYNE PHARMA INC | ANDA 205658 | — | Nov 17, 2015 | |
| HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | TRIS PHARMA INC | ANDA 203839 | — | Oct 28, 2014 | |
| HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | PADAGIS US | ANDA 204658 | — | Apr 29, 2014 |
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; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
