FDA Orange Book · active-ingredient family
Tetracaine hydrochloride
Tetracaine hydrochloride is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TETRACAINE HYDROCHLORIDE · NDA 210821
2
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TETRACAINE HYDROCHLORIDERLD | BAUSCH LOMB IRELAND | NDA 210821 | AB1 | Mar 12, 2019 | |
| TETRACAINE HYDROCHLORIDERLD | ALCON LABS | NDA 208135 | — | Feb 29, 2016 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TETRACAINE HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 217227 | AB1 | Dec 20, 2024 |
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.
Tetracaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
