Orange Book product · Generic (ANDA)
ROPIVACAINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDE
At a glance
Oct 08, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 08, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
ROPIVACAINE HYDROCHLORIDE
Strength
20MG/10ML (2MG/ML)
Dosage form
SOLUTION
Route
INJECTION
TE code
AP
Application
ANDA 219883
Product number
004
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ROPIVACAINE HYDROCHLORIDE
- 2011NAROPINBrand (NDA)
NDA 020533 · FRESENIUS KABI USA
- 2024ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211907 · HIKMA
- 2024ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218713 · KINDOS
- 2023ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206091 · MYLAN LABS LTD
- 2023ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216605 · AMNEAL
- 2022ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210102 · GLAND
- 2020ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214074 · HIKMA
- 2020ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212808 · CAPLIN
- 2018ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207636 · SOMERSET THERAPS LLC
- 2018ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206166 · INFORLIFE
- 2018ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204636 · RISING
- 2016ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205612 · EUGIA PHARMA
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.
