Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019898
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAVACHOL PRAVASTATIN SODIUM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
PRAVACHOL PRAVASTATIN SODIUM 20MG TABLET;ORAL Prescription AB Yes No
PRAVACHOL PRAVASTATIN SODIUM 40MG TABLET;ORAL Prescription AB Yes No
PRAVACHOL PRAVASTATIN SODIUM 80MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/31/1991 ORIG-1 Approval Type 1 - New Molecular Entity 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
01/23/2017 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

07/05/2016 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019898s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019898Orig1s066ltr.pdf
05/29/2013 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

10/31/2012 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898Orig1s063,s064ltr.pdf
10/31/2012 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898Orig1s063,s064ltr.pdf
02/28/2012 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898s062ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019898s062.pdf
05/18/2011 SUPPL-61 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019898s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019898s061ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019898Orig1s061.pdf
02/28/2007 SUPPL-60 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019898s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019898s060ltr.pdf
07/06/2005 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019898s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019898s058ltr.pdf
09/05/2003 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19898slr054_pravachol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19898slr054ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019898_s054_PRAVACHOL TABS.pdf
10/29/2002 SUPPL-52 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898se5-052ltr.pdf
06/14/2002 SUPPL-51 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_S051_PRAVACOL_TABLETS.pdf
07/12/2002 SUPPL-50 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s50lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898slr050ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_s050_PRAVACHOL TABS.pdf
01/14/2002 SUPPL-49 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_S049_PRAVACOL_TABLETS.pdf
12/18/2001 SUPPL-46 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s46lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898s46ltr.pdf
08/13/2001 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/14/2001 SUPPL-44 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019898_s044_PRAVACHOL TABS.pdf
03/12/2001 SUPPL-43 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019898_s043_PRAVACHOL TABS.pdf
06/15/2001 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s42lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19898S42ltr.pdf
08/24/2000 SUPPL-41 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_s041_PRAVACHOL_TABLETS.pdf
06/23/2000 SUPPL-37 Efficacy-Labeling Change With Clinical Data Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_s037_PRAVACHOL_TABLETS.pdf
09/13/1999 SUPPL-36 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_s036_PRAVACHOL_TABLETS.pdf
10/14/1999 SUPPL-35 Manufacturing (CMC) Letter (PDF)
Review (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19898s34ltr.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898s34_Pravachol.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898S34.PDF
10/14/1999 SUPPL-34 Efficacy-New Indication Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19898s34ltr.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898s34_Pravachol.pdf
02/10/2000 SUPPL-32 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/19898S32LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898s032_Pravastatin.cfm
06/09/2000 SUPPL-31 Efficacy-New Indication Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S31LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_S031_PRAVACHOL_TABLETS_AP.pdf
01/18/2000 SUPPL-30 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF
01/18/2000 SUPPL-29 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF
01/18/2000 SUPPL-27 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF
01/18/2000 SUPPL-26 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF
04/09/1999 SUPPL-25 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S025_PRAVACHOL_TABLETS.pdf
01/28/1999 SUPPL-24 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S024_PRAVACHOL_TABLETS.pdf
02/11/1999 SUPPL-23 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S023_PRAVACHOL_TABLETS.pdf
10/26/1998 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/17/1998 SUPPL-21 Labeling

Label is not available on this site.

03/11/1998 SUPPL-20 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19898-S020_Pravachol.pdf
05/20/1998 SUPPL-19 Labeling

Label is not available on this site.

03/27/1998 SUPPL-18 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19898-S018_Pravachol.pdf
04/15/1997 SUPPL-17 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019898a_s017_041597.pdf
04/04/1996 SUPPL-16 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019898_S016_PRAVACOL_TABLETS.pdf
07/02/1996 SUPPL-15 Efficacy-New Indication

Label is not available on this site.

02/28/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1996 SUPPL-13 Efficacy-New Indication

Label is not available on this site.

04/30/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1994 SUPPL-11 Labeling

Label is not available on this site.

03/30/1995 SUPPL-10 Labeling

Label is not available on this site.

03/02/1994 SUPPL-9 Labeling

Label is not available on this site.

02/09/1994 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/08/1994 SUPPL-7 Labeling

Label is not available on this site.

07/23/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1992 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/22/1993 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1993 SUPPL-3 Labeling

Label is not available on this site.

03/18/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/05/2016 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019898s066lbl.pdf
10/31/2012 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf
10/31/2012 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf
02/28/2012 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062lbl.pdf
05/18/2011 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019898s061lbl.pdf
02/28/2007 SUPPL-60 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019898s060lbl.pdf
07/06/2005 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019898s058lbl.pdf
09/05/2003 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19898slr054_pravachol_lbl.pdf
10/29/2002 SUPPL-52 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s052lbl.pdf
07/12/2002 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s50lbl.pdf
12/18/2001 SUPPL-46 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s46lbl.pdf
06/15/2001 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s42lbl.pdf

PRAVACHOL

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 076397 APNAR PHARMA LP
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 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
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 076397 APNAR PHARMA LP
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 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
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 077491 APNAR PHARMA LP
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 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English