Orange Book product · Generic (ANDA)
PRAVASTATIN SODIUM
PRAVASTATIN SODIUM
At a glance
Nov 17, 2016
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 17, 2016
9 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
PRAVASTATIN SODIUM
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 207068
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PRAVASTATIN SODIUM
- 1991PRAVACHOLBrand (NDA)
NDA 019898 · BRISTOL MYERS SQUIBB
- 2018PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 206061 · HISUN PHARM HANGZHOU
- 2018PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 209869 · BIOCON PHARMA
- 2017PRAVASTATIN SODIUMGeneric (ANDA)
ANDA 203367 · AUROBINDO PHARMA
- 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.

