Orange Book product · Generic (ANDA)
AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE
At a glance
Jul 21, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 21, 2020
6 yr ago
Today
Pharmaceutical detail
Active ingredient
AMIODARONE HYDROCHLORIDE
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213446
Product number
001
Marketing status
RX
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
- 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
- 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.
