FDA Orange Book · active-ingredient family
Epinephrine bitartrate; prilocaine hydrochloride
Epinephrine bitartrate; prilocaine 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:CITANEST FORTE DENTAL · NDA 021383
2
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CITANEST FORTE DENTALRLD | DENTSPLY PHARM | NDA 021383 | AP | Approved Prior to Jan 1, 1982 | |
| CITANEST FORTE | ASTRAZENECA | NDA 014763 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | SEPTODONT INC | ANDA 078959 | AP | Aug 30, 2011 |
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; prilocaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
