Orange Book product · Brand (NDA)
RYTHMOL
PROPAFENONE HYDROCHLORIDE
At a glance
Nov 27, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 27, 1989
37 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
PROPAFENONE HYDROCHLORIDE
Strength
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 019151
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.
- 2003RYTHMOL SRBrand (NDA)
NDA 021416 · 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.
