Orange Book product · Generic (ANDA)
SIMVASTATIN
SIMVASTATIN
At a glance
Apr 05, 2013
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 05, 2013
13 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
SIMVASTATIN
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 078155
Product number
005
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SIMVASTATIN
- 2016FLOLIPIDBrand (NDA)
NDA 206679 · SALERNO PHARMS
- 2007SIMVASTATINBrand (NDA)
NDA 021961 · SYNTHON 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
- 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.
