FDA Orange Book · active-ingredient family
Epinephrine bitartrate; etidocaine hydrochloride
Epinephrine bitartrate; etidocaine hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DURANEST · NDA 017751
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DURANESTRLD×2 | ASTRAZENECA | NDA 017751 | — | Approved Prior to Jan 1, 1982 | |
| DURANESTRLD | DENTSPLY PHARM | NDA 021384 | — | 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.
Epinephrine bitartrate; etidocaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
