FDA Orange Book · active-ingredient family
Articaine hydrochloride; epinephrine bitartrate
Articaine hydrochloride; epinephrine bitartrate is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ORABLOC · NDA 022466
2
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ORABLOCRLD×2 | PIERREL | NDA 022466 | — | Feb 26, 2010 | |
| SEPTOCAINERLD×2 | DEPROCO | NDA 020971 | — | Mar 30, 2006 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ULTACAN | HANSAMED INC | ANDA 201751 | — | Jul 11, 2017 | |
| ULTACAN FORTE | HANSAMED INC | ANDA 201750 | — | Jul 11, 2017 | |
| ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | HOSPIRA | ANDA 079138 | — | Jun 18, 2010 |
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.
Articaine hydrochloride; epinephrine bitartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
