FDA Orange Book · active-ingredient family
Propafenone hydrochloride
Propafenone hydrochloride is approved as 2 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RYTHMOL SR · NDA 021416
2
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RYTHMOL SRRLD×3 | GLAXOSMITHKLINE LLC | NDA 021416 | — | Sep 04, 2003 | |
| RYTHMOLRLD×3 | GLAXOSMITHKLINE LLC | NDA 019151 | — | Nov 27, 1989 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROPAFENONE HYDROCHLORIDE×3 | AUROBINDO PHARMA LTD | ANDA 213096 | AB | Feb 21, 2023 | |
| PROPAFENONE HYDROCHLORIDE×3 | ZYDUS LIFESCIENCES | ANDA 214184 | AB | Apr 21, 2021 | |
| PROPAFENONE HYDROCHLORIDE×3 | UPSHER SMITH LABS | ANDA 212744 | AB | Jun 25, 2020 | |
| PROPAFENONE HYDROCHLORIDE×3 | TWI PHARMS | ANDA 212928 | — | Jun 18, 2020 | |
| PROPAFENONE HYDROCHLORIDE×3 | SINOTHERAPEUTICS INC | ANDA 210339 | AB | Jan 04, 2019 | |
| PROPAFENONE HYDROCHLORIDE×3 | RISING | ANDA 205956 | AB | Jul 02, 2018 | |
| PROPAFENONE HYDROCHLORIDE×3 | GLENMARK PHARMS LTD | ANDA 205268 | AB | Sep 08, 2017 | |
| PROPAFENONE HYDROCHLORIDE×3 | AUROBINDO PHARMA | ANDA 202445 | AB | May 11, 2016 | |
| PROPAFENONE HYDROCHLORIDE×3 | MYLAN | ANDA 203803 | — | Apr 29, 2016 | |
| PROPAFENONE HYDROCHLORIDE×3 | WATSON LABS INC | ANDA 202688 | AB | Aug 24, 2015 | |
| PROPAFENONE HYDROCHLORIDE×3 | STRIDES PHARMA INTL | ANDA 078540 | AB | Oct 18, 2010 | |
| PROPAFENONE HYDROCHLORIDE×3 | ANI PHARMS | ANDA 076550 | AB | Apr 23, 2004 | |
| PROPAFENONE HYDROCHLORIDE×3 | STRIDES PHARMA INTL | ANDA 075938 | AB | Oct 17, 2002 | |
| PROPAFENONE HYDROCHLORIDE×3 | NESHER PHARMS | ANDA 076193 | — | Feb 07, 2002 | |
| PROPAFENONE HYDROCHLORIDE×3 | SUN PHARM INDUSTRIES | ANDA 075998 | — | Nov 29, 2001 | |
| PROPAFENONE HYDROCHLORIDE×2 | WATSON LABS | ANDA 075203 | AB | Oct 24, 2000 |
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.
Propafenone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
