Orange Book product · Brand (NDA)
RANEXA
RANOLAZINE
At a glance
Feb 12, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 12, 2007
19 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
RANOLAZINE
Strength
1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021526
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.
- 2022ASPRUZYO SPRINKLEBrand (NDA)
NDA 216018 · SPIL
- 2025RANOLAZINEGeneric (ANDA)
ANDA 211361 · JUBILANT GENERICS
- 2025RANOLAZINEGeneric (ANDA)
ANDA 210407 · TORRENT
- 2023RANOLAZINEGeneric (ANDA)
ANDA 210668 · NOVAST LABS
- 2023RANOLAZINEGeneric (ANDA)
ANDA 213085 · PIRAMAL
- 2023RANOLAZINEGeneric (ANDA)
ANDA 213083 · UNICHEM
- 2022RANOLAZINEGeneric (ANDA)
ANDA 209081 · AUROBINDO PHARMA
- 2022RANOLAZINEGeneric (ANDA)
ANDA 212788 · HETERO LABS LTD III
- 2022RANOLAZINEGeneric (ANDA)
ANDA 213517 · I3 PHARMS
- 2022RANOLAZINEGeneric (ANDA)
ANDA 214035 · VKT PHARMA
- 2021RANOLAZINEGeneric (ANDA)
ANDA 212930 · ACCORD HLTHCARE
- 2021RANOLAZINEGeneric (ANDA)
ANDA 207690 · AMNEAL
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.
