FDA Orange Book · active-ingredient family
Bupivacaine hydrochloride; lidocaine hydrochloride
Bupivacaine hydrochloride; lidocaine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DUOCAINE · NDA 021496
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DUOCAINE | AMPHASTAR PHARMS INC | NDA 021496 | — | May 23, 2003 |
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.
Bupivacaine hydrochloride; lidocaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
