Orange Book product · Brand (NDA)
ZOCOR
SIMVASTATIN
At a glance
Dec 23, 1991
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 1991
35 yr ago
Today
Pharmaceutical detail
Active ingredient
SIMVASTATIN
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 019766
Product number
001
Marketing status
RX
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.
- 2016FLOLIPIDBrand (NDA)
NDA 206679 · SALERNO PHARMS
- 2007SIMVASTATINBrand (NDA)
NDA 021961 · SYNTHON PHARMS
- 2025SIMVASTATINGeneric (ANDA)
ANDA 206557 · INVAGEN PHARMS
- 2024SIMVASTATINGeneric (ANDA)
ANDA 211394 · YILING
- 2014SIMVASTATINGeneric (ANDA)
ANDA 200895 · HETERO LABS LTD III
- 2013SIMVASTATINGeneric (ANDA)
ANDA 078155 · ACCORD HLTHCARE
- 2011SIMVASTATINGeneric (ANDA)
ANDA 090383 · MICRO LABS
- 2010SIMVASTATINGeneric (ANDA)
ANDA 078735 · OXFORD PHARMS
- 2010SIMVASTATINGeneric (ANDA)
ANDA 090868 · PHARMOBEDIENT
- 2009SIMVASTATINGeneric (ANDA)
ANDA 078103 · LUPIN
- 2008SIMVASTATINGeneric (ANDA)
ANDA 077752 · RISING
- 2006SIMVASTATINGeneric (ANDA)
ANDA 077691 · AUROBINDO PHARMA
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.
