Orange Book product · Generic (ANDA)
BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE
At a glance
Jun 23, 2023
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 23, 2023
3 yr ago
Today
Pharmaceutical detail
Active ingredient
BUPIVACAINE HYDROCHLORIDE
Strength
0.25%
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 216039
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUPIVACAINE HYDROCHLORIDE
- 2020XARACOLLBrand (NDA)
NDA 209511 · INNOCOLL PHARMS
- 1992BUPIVACAINE HYDROCHLORIDE KITBrand (NDA)
NDA 019978 · HOSPIRA
- 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
- 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.
