FDA Orange Book · active-ingredient family
Chlorpheniramine maleate; hydrocodone bitartrate
Chlorpheniramine maleate; hydrocodone bitartrate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VITUZ · NDA 204307
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VITUZRLD | PERSION | NDA 204307 | — | Feb 20, 2013 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE | ACELLA | ANDA 206891 | — | Jun 09, 2017 | |
| HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE | TRIS PHARMA INC | ANDA 206438 | — | Jan 27, 2015 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
