Orange Book product · Generic (ANDA)
EZETIMIBE AND SIMVASTATIN
EZETIMIBE; SIMVASTATIN
At a glance
Nov 21, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 21, 2017
8 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
EZETIMIBE; SIMVASTATIN
Strength
10MG;10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 208831
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EZETIMIBE; SIMVASTATIN
- 2004VYTORINBrand (NDA)
NDA 021687 · ORGANON
- 2025EZETIMIBE AND SIMVASTATINGeneric (ANDA)
ANDA 209461 · TORRENT
- 2024EZETIMIBE AND SIMVASTATINGeneric (ANDA)
ANDA 211663 · SCIEGEN PHARMS
- 2020EZETIMIBE AND SIMVASTATINGeneric (ANDA)
ANDA 200082 · AUROBINDO PHARMA USA
- 2019EZETIMIBE AND SIMVASTATINGeneric (ANDA)
ANDA 208699 · GLENMARK PHARMS LTD
- 2017EZETIMIBE AND SIMVASTATINGeneric (ANDA)
ANDA 209222 · ALKEM LABS LTD
- 2017EZETIMIBE AND SIMVASTATINGeneric (ANDA)
ANDA 201890 · ANI PHARMS
- 2017EZETIMIBE AND SIMVASTATINGeneric (ANDA)
ANDA 200909 · DR REDDYS LABS SA
- 2017EZETIMIBE AND SIMVASTATINGeneric (ANDA)
ANDA 202968 · WATSON LABS INC
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.
