Orange Book product · Generic (ANDA)
VIVACAINE
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
At a glance
Sep 27, 2006
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 27, 2006
20 yr 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
ANDA 077250
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
- 1983SENSORCAINEBrand (NDA)
NDA 018304 · FRESENIUS KABI USA
- 1983BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEBrand (NDA)
NDA 022046 · HOSPIRA
- —MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBrand (NDA)
NDA 016964 · HOSPIRA
- 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.
