Orange Book product · Generic (ANDA)
PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE
At a glance
Oct 18, 2010
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 18, 2010
15 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
PROPAFENONE HYDROCHLORIDE
Strength
425MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 078540
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of PROPAFENONE HYDROCHLORIDE
- 2003RYTHMOL SRBrand (NDA)
NDA 021416 · GLAXOSMITHKLINE LLC
- 1989RYTHMOLBrand (NDA)
NDA 019151 · GLAXOSMITHKLINE LLC
- 2023PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 213096 · AUROBINDO PHARMA LTD
- 2021PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 214184 · ZYDUS LIFESCIENCES
- 2020PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212744 · UPSHER SMITH LABS
- 2020PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212928 · TWI PHARMS
- 2019PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 210339 · SINOTHERAPEUTICS INC
- 2018PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 205956 · RISING
- 2017PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 205268 · GLENMARK PHARMS LTD
- 2016PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 202445 · AUROBINDO PHARMA
- 2016PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 203803 · MYLAN
- 2015PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 202688 · WATSON LABS INC
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.
