Orange Book product · Generic (ANDA)
CAPECITABINE
CAPECITABINE
At a glance
Oct 23, 2023
Approved
Generic (ANDA)
Application
BX
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 23, 2023
2 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CAPECITABINE
Strength
150MG
Dosage form
TABLET
Route
ORAL
TE code
BX
Application
ANDA 217237
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CAPECITABINE
- 1998XELODABrand (NDA)
NDA 020896 · CHEPLAPHARM
- 2024CAPECITABINEGeneric (ANDA)
ANDA 210203 · HETERO LABS LTD V
- 2020CAPECITABINEGeneric (ANDA)
ANDA 204345 · DR REDDYS
- 2020CAPECITABINEGeneric (ANDA)
ANDA 211724 · RELIANCE LIFE
- 2019CAPECITABINEGeneric (ANDA)
ANDA 204668 · SUN PHARM
- 2018CAPECITABINEGeneric (ANDA)
ANDA 209365 · MSN
- 2018CAPECITABINEGeneric (ANDA)
ANDA 210604 · EUGIA PHARMA
- 2017CAPECITABINEGeneric (ANDA)
ANDA 207652 · ALKEM LABS LTD
- 2017CAPECITABINEGeneric (ANDA)
ANDA 204741 · AMNEAL PHARMS
- 2016CAPECITABINEGeneric (ANDA)
ANDA 207456 · SHILPA
- 2016CAPECITABINEGeneric (ANDA)
ANDA 200483 · HIKMA
- 2015CAPECITABINEGeneric (ANDA)
ANDA 202593 · ACCORD HLTHCARE
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.
