FDA Orange Book · active-ingredient family
Chlorpheniramine polistirex; codeine polistirex
Chlorpheniramine polistirex; codeine polistirex is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TUZISTRA XR · NDA 207768
3
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TUZISTRA XRRLD | TRIS PHARMA INC | NDA 207768 | — | Apr 30, 2015 | |
| CODEPREX | LANNETT CO INC | NDA 021369 | — | Jun 21, 2004 | |
| PENNTUSS | FISONS | NDA 018928 | — | Aug 14, 1985 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8790700 | Mar 15, 2027 | in 9 mo | Product |
| 8062667 | Mar 29, 2029 | in 2 yr 10 mo | Product |
Chlorpheniramine polistirex; codeine polistirex — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
