Orange Book product · Brand (NDA)
NAROPIN
ROPIVACAINE HYDROCHLORIDE
At a glance
Jan 04, 2011
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 04, 2011
15 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ROPIVACAINE HYDROCHLORIDE
Strength
1GM/200ML (5MG/ML)
Dosage form
SOLUTION
Route
INJECTION
TE code
AP
Application
NDA 020533
Product number
010
Marketing status
RX
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.
- 2025ROPIVACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219883 · ANTHEA PHARMA
- 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.
