Orange Book product · Generic (ANDA)
PRAVASTATIN SODIUM
PRAVASTATIN SODIUM
At a glance
Jan 15, 2008
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 15, 2008
18 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
PRAVASTATIN SODIUM
Strength
80MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 077793
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of PRAVASTATIN SODIUM
- 1991PRAVACHOLBrand (NDA)
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- 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 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.
