Orange Book product · Brand (NDA)
ALTOPREV
LOVASTATIN
At a glance
Jun 26, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 26, 2002
24 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
LOVASTATIN
Strength
20MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021316
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.
- 1991MEVACORBrand (NDA)
NDA 019643 · MERCK
- 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.
