Orange Book product · Generic (ANDA)
RANOLAZINE
RANOLAZINE
At a glance
Apr 27, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 27, 2022
4 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
RANOLAZINE
Strength
1GM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 213517
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of RANOLAZINE
- 2022ASPRUZYO SPRINKLEBrand (NDA)
NDA 216018 · SPIL
- 2007RANEXABrand (NDA)
NDA 021526 · MENARINI INTL
- 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 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.
