FDA Orange Book · active-ingredient family
Chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride
Chlorpheniramine maleate; 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:ZUTRIPRO · NDA 022439
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZUTRIPRORLD | PERSION | NDA 022439 | — | Jun 08, 2011 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | SCIEGEN PHARMS | ANDA 206660 | — | May 15, 2017 | |
| HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | MAYNE PHARMA INC | ANDA 205657 | — | Aug 03, 2015 | |
| HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | TRIS PHARMA INC | ANDA 203838 | — | Nov 26, 2014 | |
| HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | PADAGIS US | ANDA 204627 | — | 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.
Chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
