Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019898
Company: BRISTOL MYERS SQUIBB
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| PRAVACHOL | PRAVASTATIN SODIUM | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PRAVACHOL | PRAVASTATIN SODIUM | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PRAVACHOL | PRAVASTATIN SODIUM | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PRAVACHOL | PRAVASTATIN SODIUM | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/31/1991 | 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 |
|---|---|---|---|---|---|
| 05/31/2022 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019898s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019898Orig1s070ltr.pdf | |
| 09/25/2020 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019898s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019898Orig1s069ltr.pdf | |
| 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.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898s34_Pravachol.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 |
|---|---|---|---|---|---|
| 05/31/2022 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019898s070lbl.pdf | |
| 09/25/2020 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019898s069lbl.pdf | |
| 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 |