Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076939
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription AB No No
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription AB No No
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription AB No No
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG 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
10/23/2006 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/20/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/19/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/28/2007 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/2007 SUPPL-1 Labeling

Label is not available on this site.

PRAVASTATIN SODIUM

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRAVACHOL PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription Yes AB 019898 BRISTOL MYERS SQUIBB
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 207068 ACCORD HLTHCARE
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 076341 APOTEX INC
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 CHARTWELL RX
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 206061 HISUN PHARM HANGZHOU
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 077917 LUPIN PHARMS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 079187 MYLAN PHARMS INC
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription No AB 077491 SANDOZ
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

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRAVACHOL PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription Yes AB 019898 BRISTOL MYERS SQUIBB
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 207068 ACCORD HLTHCARE
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 076341 APOTEX INC
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 CHARTWELL RX
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 206061 HISUN PHARM HANGZHOU
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 077917 LUPIN PHARMS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 079187 MYLAN PHARMS INC
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription No AB 076397 SANDOZ
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; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRAVACHOL PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription Yes AB 019898 BRISTOL MYERS SQUIBB
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 207068 ACCORD HLTHCARE
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 076341 APOTEX INC
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 CHARTWELL RX
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 206061 HISUN PHARM HANGZHOU
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 077917 LUPIN PHARMS
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 079187 MYLAN PHARMS INC
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription No AB 076397 SANDOZ
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; 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 076341 APOTEX INC
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 CHARTWELL RX
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 079187 MYLAN PHARMS INC
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 076397 SANDOZ
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
PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET;ORAL Prescription No AB 077751 ZYDUS PHARMS USA

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