Orange Book product · Brand (NDA)
PRAVACHOL
PRAVASTATIN SODIUM
At a glance
Oct 31, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 1991
35 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
PRAVASTATIN SODIUM
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10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019898
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.
- 2018PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 206061 · HISUN PHARM HANGZHOU
- 2018PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 209869 · BIOCON PHARMA
- 2017PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 203367 · AUROBINDO PHARMA
- 2016PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 207068 · ACCORD HLTHCARE
- 2010PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 079187 · PHARMOBEDIENT
- 2008PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 077751 · ZYDUS PHARMS USA
- 2008PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 077793 · AUROBINDO PHARMA USA
- 2008PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 077917 · CHARTWELL RX
- 2007PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 077987 · GLENMARK PHARMS LTD
- 2007PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 076445 · RANBAXY LABS LTD
- 2006PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 077730 · PLIVA HRVATSKA DOO
- 2006PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 076341 · APOTEX
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.
