FDA Orange Book · active-ingredient family
Pseudoephedrine hydrochloride; triprolidine hydrochloride
Pseudoephedrine hydrochloride; triprolidine hydrochloride is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACTIFED · NDA 018996
1
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, syrup, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACTIFED | GLAXOSMITHKLINE | NDA 018996 | — | Jun 17, 1985 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES | KV PHARM | ANDA 072758 | — | Nov 25, 1991 | |
| TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES | KV PHARM | ANDA 071798 | — | Mar 16, 1989 | |
| CORPHED | CHARTWELL RX | ANDA 088602 | — | Apr 11, 1985 | |
| TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | SUPERPHARM | ANDA 088578 | — | Feb 21, 1985 | |
| TRILITRON | NEWTRON PHARMS | ANDA 088474 | — | Feb 12, 1985 | |
| ALLERFED | PVT FORM | ANDA 088860 | — | Jan 31, 1985 | |
| TRILITRON | NEWTRON PHARMS | ANDA 088515 | — | Jan 09, 1985 | |
| TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | IVAX SUB TEVA PHARMS | ANDA 085273 | — | Dec 12, 1984 | |
| TRIPHED | TEVA | ANDA 088630 | — | May 17, 1984 | |
| HISTAFED | CENCI | ANDA 088283 | — | Apr 20, 1984 | |
| ACTAHIST | CENCI | ANDA 088344 | — | Feb 09, 1984 | |
| TRIPROLIDINE AND PSEUDOEPHEDRINE | WATSON LABS | ANDA 088318 | — | Jan 13, 1984 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE | SANDOZ | ANDA 088193 | — | May 17, 1983 | |
| TRIPROLIDINE AND PSEUDOEPHEDRINE | WEST WARD | ANDA 088117 | — | Apr 19, 1983 | |
| MYFED | USL PHARMA | ANDA 088116 | — | Mar 04, 1983 |
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.
Pseudoephedrine hydrochloride; triprolidine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
