Orange Book product · Generic (ANDA)
AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE
At a glance
Apr 20, 2005
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 20, 2005
21 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
AMIODARONE HYDROCHLORIDE
Strength
50MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 077161
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of AMIODARONE HYDROCHLORIDE
- 2008NEXTERONEBrand (NDA)
NDA 022325 · BAXTER HLTHCARE
- 2004AMIODARONE HYDROCHLORIDEBrand (NDA)
NDA 021594 · INTL MEDICATION SYS
- 1995CORDARONEBrand (NDA)
NDA 020377 · WYETH PHARMS INC
- 1985CORDARONEBrand (NDA)
NDA 018972 · WYETH PHARMS
- 2024AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 218253 · ZHEJIANG POLY PHARM
- 2023AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 079029 · ZYDUS PHARMS USA INC
- 2021AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 078578 · RUBICON RESEARCH
- 2020AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 213446 · UNICHEM
- 2017AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 075389 · DR REDDYS LABS SA
- 2017AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204550 · EUGIA PHARMA
- 2016AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 077069 · CHARTWELL RX
- 2016AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204742 · AUROBINDO PHARMA LTD
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.
