Orange Book product · Brand (NDA)
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
At a glance
Jul 13, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 13, 1983
43 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Strength
0.5%;0.0091MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 022046
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1983SENSORCAINEBrand (NDA)
NDA 018304 · FRESENIUS KABI USA
- —MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBrand (NDA)
NDA 016964 · HOSPIRA
- 2006VIVACAINEGeneric (ANDA)
ANDA 077250 · SEPTODONT
- 1987SENSORCAINEGeneric (ANDA)
ANDA 070966 · FRESENIUS KABI USA
- 1987SENSORCAINEGeneric (ANDA)
ANDA 070967 · FRESENIUS KABI USA
- 1987SENSORCAINEGeneric (ANDA)
ANDA 070968 · FRESENIUS KABI USA
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.
