Orange Book product · Brand (NDA)
SIMVASTATIN
SIMVASTATIN
At a glance
Oct 09, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 09, 2007
19 yr ago
Today
Pharmaceutical detail
Active ingredient
SIMVASTATIN
Strength
10MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 021961
Product number
001
Marketing status
DISCN
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
- 1991ZOCORBrand (NDA)
NDA 019766 · ORGANON
- 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.
