Orange Book product · Brand (NDA)
RYTHMOL SR
PROPAFENONE HYDROCHLORIDE
At a glance
Sep 04, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 04, 2003
23 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
PROPAFENONE HYDROCHLORIDE
Strength
325MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021416
Product number
002
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.
- 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
- 2010PROPAFENONE HYDROCHLORIDEGeneric (ANDA)
ANDA 078540 · STRIDES PHARMA INTL
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.
