Orange Book product · Generic (ANDA)
AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE
At a glance
Oct 25, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 25, 2017
8 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
AMIODARONE HYDROCHLORIDE
Strength
50MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 204550
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
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
- 2016AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 077069 · CHARTWELL RX
- 2016AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204742 · AUROBINDO PHARMA LTD
- 2013AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 203884 · HOSPIRA
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.
