Orange Book product · Generic (ANDA)
EZETIMIBE
EZETIMIBE
At a glance
Sep 13, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 13, 2022
3 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
EZETIMIBE
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 215693
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EZETIMIBE
- 2002ZETIABrand (NDA)
NDA 021445 · ORGANON
- 2024EZETIMIBEGeneric (ANDA)
ANDA 211159 · MACLEODS PHARMS LTD
- 2022EZETIMIBEGeneric (ANDA)
ANDA 210859 · HETERO LABS LTD III
- 2020EZETIMIBEGeneric (ANDA)
ANDA 210673 · SCIEGEN PHARMS
- 2019EZETIMIBEGeneric (ANDA)
ANDA 201790 · RISING
- 2018EZETIMIBEGeneric (ANDA)
ANDA 211550 · ACCORD HLTHCARE
- 2017EZETIMIBEGeneric (ANDA)
ANDA 209234 · ALKEM LABS LTD
- 2017EZETIMIBEGeneric (ANDA)
ANDA 209838 · AUROBINDO PHARMA
- 2017EZETIMIBEGeneric (ANDA)
ANDA 208803 · AMNEAL PHARMS CO
- 2017EZETIMIBEGeneric (ANDA)
ANDA 208332 · APOTEX
- 2017EZETIMIBEGeneric (ANDA)
ANDA 207311 · OHM LABS INC
- 2017EZETIMIBEGeneric (ANDA)
ANDA 203931 · SANDOZ
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.
