FDA Orange Book · active-ingredient family
Triazolam
Triazolam is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HALCION · NDA 017892
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALCIONRLD×3 | PFIZER | NDA 017892 | AB | Apr 26, 1985 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIAZOLAM×2 | ZYDUS PHARMS | ANDA 213003 | AB | Dec 28, 2022 | |
| TRIAZOLAM×2 | BRECKENRIDGE | ANDA 216890 | — | Nov 08, 2022 | |
| TRIAZOLAM×2 | INGENUS PHARMS LLC | ANDA 214219 | AB | Oct 20, 2020 | |
| TRIAZOLAM×2 | WATSON LABS | ANDA 074445 | — | Oct 20, 1995 | |
| TRIAZOLAM×2 | HIKMA | ANDA 074224 | — | Jun 01, 1994 | |
| TRIAZOLAM×2 | PHARMOBEDIENT | ANDA 074031 | — | Mar 25, 1994 |
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.
Triazolam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
