FDA Orange Book · active-ingredient family
Trihexyphenidyl hydrochloride
Trihexyphenidyl hydrochloride is approved as 2 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ARTANE · NDA 006773
2
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, elixir, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARTANERLD×4 | LEDERLE | NDA 006773 | — | Approved Prior to Jan 1, 1982 | |
| ARTANE | LEDERLE | NDA 012947 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIHEXYPHENIDYL HYDROCHLORIDE×2 | NATCO PHARMA LTD | ANDA 091630 | AA | Nov 17, 2010 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE×2 | HIKMA | ANDA 040337 | — | Feb 16, 2000 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE | CHARTWELL RX | ANDA 040251 | AA | Sep 27, 1999 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE×2 | NOVITIUM PHARMA | ANDA 040254 | AA | Dec 24, 1998 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE×2 | WATSON LABS | ANDA 040184 | — | Feb 06, 1998 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE | PHARM ASSOC | ANDA 040177 | AA | Apr 17, 1997 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE | PHARM VENTURES | ANDA 089514 | — | Apr 07, 1989 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE | VANGARD | ANDA 088035 | — | Jul 30, 1982 | |
| TREMIN×2 | SCHERING | ANDA 080381 | — | Approved Prior to Jan 1, 1982 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE | NYLOS | ANDA 085622 | — | Approved Prior to Jan 1, 1982 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE | WATSON LABS | ANDA 084363 | AA | Approved Prior to Jan 1, 1982 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE | WATSON LABS | ANDA 085117 | — | Approved Prior to Jan 1, 1982 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE | WATSON LABS | ANDA 084364 | AA | Approved Prior to Jan 1, 1982 | |
| TRIHEXYPHENIDYL HYDROCHLORIDE | WATSON LABS | ANDA 085105 | — | 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.
Trihexyphenidyl hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
