FDA Orange Book · active-ingredient family
Tripelennamine hydrochloride
Tripelennamine hydrochloride is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PBZ-SR · NDA 010533
2
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PBZ | NOVARTIS | ANDA 083149 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | ANABOLIC | ANDA 083037 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | BARR | ANDA 080744 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | HEATHER | ANDA 083989 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | IMPAX LABS | ANDA 080785 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | LANNETT | ANDA 083557 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | NYLOS | ANDA 085412 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | PARKE DAVIS | ANDA 083625 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | PARKE DAVIS | ANDA 083626 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | WATSON LABS | ANDA 080713 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | WATSON LABS | ANDA 080790 | — | Approved Prior to Jan 1, 1982 | |
| TRIPELENNAMINE HYDROCHLORIDE | WATSON LABS | ANDA 085188 | — | Approved Prior to Jan 1, 1982 |
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.
Tripelennamine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
