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Abbreviated New Drug Application (ANDA): 207068
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription AB No No
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription AB No No
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription AB No No
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/17/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/05/2021 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

PRAVASTATIN SODIUM

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 207068 ACCORD HLTHCARE
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 077491 APNAR PHARMA LP
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 076341 APOTEX
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 203367 AUROBINDO PHARMA LTD
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 209869 BIOCON PHARMA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 077904 CIPLA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 076714 DR REDDYS LABS INC
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 077987 GLENMARK GENERICS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 077917 LUPIN PHARMS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 076056 TEVA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 076939 WATSON LABS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 207068 ACCORD HLTHCARE
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 077491 APNAR PHARMA LP
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 076341 APOTEX
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 203367 AUROBINDO PHARMA LTD
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 209869 BIOCON PHARMA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 077904 CIPLA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 076714 DR REDDYS LABS INC
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 077987 GLENMARK GENERICS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 077917 LUPIN PHARMS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 076056 TEVA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 076939 WATSON LABS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 077751 ZYDUS PHARMS USA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 207068 ACCORD HLTHCARE
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 077491 APNAR PHARMA LP
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 076341 APOTEX
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 203367 AUROBINDO PHARMA LTD
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 209869 BIOCON PHARMA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 077904 CIPLA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 076714 DR REDDYS LABS INC
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 077987 GLENMARK GENERICS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 077917 LUPIN PHARMS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 076056 TEVA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 076939 WATSON LABS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 077751 ZYDUS PHARMS USA

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 207068 ACCORD HLTHCARE
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 077491 APNAR PHARMA LP
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 076341 APOTEX
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 203367 AUROBINDO PHARMA LTD
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 209869 BIOCON PHARMA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 077904 CIPLA
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 076714 DR REDDYS LABS INC
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 077987 GLENMARK GENERICS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 077917 LUPIN PHARMS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 077793 TEVA PHARMS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 076939 WATSON LABS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 077751 ZYDUS PHARMS USA
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