FDA Orange Book · active-ingredient family
Chlorpheniramine polistirex; hydrocodone polistirex
Chlorpheniramine polistirex; hydrocodone polistirex is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TUSSIONEX PENNKINETIC · NDA 019111
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, suspension, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TUSSIONEX PENNKINETICRLD | UCB INC | NDA 019111 | — | Dec 31, 1987 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX | NEOS THERAPS INC | ANDA 091671 | — | Jun 29, 2012 | |
| HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX | TRIS PHARMA INC | ANDA 091632 | — | Oct 01, 2010 | |
| TUSSICAPS×2 | ECR PHARMA | ANDA 077273 | — | Sep 24, 2007 |
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 polistirex; hydrocodone polistirex — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
