FDA Orange Book · active-ingredient family
Codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride
Codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride 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:ACTIFED W/ CODEINE · NDA 012575
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · syrup
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACTIFED W/ CODEINE | GLAXOSMITHKLINE | NDA 012575 | — | Apr 04, 1984 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE | CENCI | ANDA 089018 | — | Jul 23, 1986 | |
| TRIACIN-C | ANIMA | ANDA 088704 | — | Mar 22, 1985 | |
| TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE | WOCKHARDT | ANDA 088833 | — | Nov 16, 1984 |
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.
Codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
