Orange Book product · Brand (NDA)
BUPIVACAINE HYDROCHLORIDE KIT
BUPIVACAINE HYDROCHLORIDE
At a glance
Sep 03, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 03, 1992
34 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
BUPIVACAINE HYDROCHLORIDE
Strength
0.114%
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019978
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2020XARACOLLBrand (NDA)
NDA 209511 · INNOCOLL PHARMS
- 1984MARCAINEBrand (NDA)
NDA 018692 · HOSPIRA
- —BUPIVACAINE HYDROCHLORIDEBrand (NDA)
NDA 018053 · HOSPIRA
- —MARCAINE HYDROCHLORIDEBrand (NDA)
NDA 016964 · HOSPIRA
- —SENSORCAINEBrand (NDA)
NDA 018304 · FRESENIUS KABI USA
- 2026BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220493 · ANTHEA PHARMA
- 2024BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217821 · ASPIRO
- 2023BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216040 · MEITHEAL
- 2023BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217792 · SOMERSET
- 2023BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216039 · MEITHEAL
- 2021BUPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205141 · HIKMA PHARMS
- 2021BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 204842 · HIKMA PHARMS
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.
