Orange Book product · Brand (NDA)
MEVACOR
LOVASTATIN
At a glance
Mar 28, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 28, 1991
35 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
LOVASTATIN
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 019643
Product number
002
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.
- 2002ALTOPREVBrand (NDA)
NDA 021316 · AZURITY
- 2008LOVASTATINGeneric (ANDA)
ANDA 078296 · LUPIN
- 2007LOVASTATINGeneric (ANDA)
ANDA 077748 · COREPHARMA
- 2006LOVASTATINGeneric (ANDA)
ANDA 077520 · SUN PHARM INDUSTRIES
- 2002LOVASTATINGeneric (ANDA)
ANDA 075991 · CARLSBAD
- 2001LOVASTATINGeneric (ANDA)
ANDA 075828 · ACTAVIS ELIZABETH
- 2001LOVASTATINGeneric (ANDA)
ANDA 075451 · AUROBINDO PHARMA USA
- 2001LOVASTATINGeneric (ANDA)
ANDA 075935 · AUROBINDO PHARMA USA
- 2001LOVASTATINGeneric (ANDA)
ANDA 075300 · CHARTWELL RX
- 2001LOVASTATINGeneric (ANDA)
ANDA 075636 · EPIC PHARMA LLC
- 2001LOVASTATINGeneric (ANDA)
ANDA 075551 · TEVA
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.
