Orange Book product · Brand (NDA)
NEXTERONE
AMIODARONE HYDROCHLORIDE
At a glance
Dec 24, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 2008
17 yr 9 mo ago
Today
Patent 7635773 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Pharmaceutical detail
Active ingredient
AMIODARONE HYDROCHLORIDE
Strength
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 022325
Product number
001
Marketing status
DISCN
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.
- 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
- 2013AMIODARONE HYDROCHLORIDEGeneric (ANDA)
ANDA 203884 · HOSPIRA
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7635773 | Mar 13, 2029 | in 2 yr 9 mo | Product |
