Application 019898

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002PRAVACHOLPRAVASTATIN SODIUMTABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003PRAVACHOLPRAVASTATIN SODIUMTABLET;ORAL20MGYesNo
004PRAVACHOLPRAVASTATIN SODIUMTABLET;ORAL40MGYesNo
008PRAVACHOLPRAVASTATIN SODIUMTABLET;ORAL80MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019898-002PRAVACHOLPRAVASTATIN SODIUM10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31
N019898-003PRAVACHOLPRAVASTATIN SODIUM20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31
N019898-004PRAVACHOLPRAVASTATIN SODIUM40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-22
N019898-008PRAVACHOLPRAVASTATIN SODIUM80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-3184e616aacf4f…
2026-09-14 22:38:342026-08N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-3184e616aacf4f…
2026-09-14 22:38:342026-08N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-2284e616aacf4f…
2026-09-14 22:38:342026-08N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-1884e616aacf4f…
2026-08-18 06:07:402026-07N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019898-002PRAVACHOL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019898-003PRAVACHOL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019898-004PRAVACHOL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019898-008PRAVACHOL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2001-12-185bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N019898-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019898-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019898-008AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019898-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019898-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019898-008AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N019898-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019898-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019898-008AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019898-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019898-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019898-008AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019898-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019898-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019898-008AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019898-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N019898-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N019898-008AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N019898-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N019898-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N019898-008AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019898-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N019898-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N019898-008AB1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pravastatin sodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.e6a3d99c-c9cc-49d9-b0f9-503770307b702025-10-31Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack03e27551-b3bf-47dd-b3ec-cd9a66ace3c42025-10-30Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
Pravastatin sodiumPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.3ef390a6-e0a0-331d-e063-6394a90a83d02025-10-27Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions45f0fd53-7160-4361-ba0b-3401095441c42025-10-15Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions635062df-9a84-4ff8-874c-dcee581a55552025-10-15Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions33c141e9-76dc-4e32-9b2a-4621f32ac4bd2025-07-24Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions72693449-01ee-42b0-9902-5662523245792025-07-24Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4015f184-b57e-4d32-9cef-15c6e1cefe242025-05-28Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsb7a84cc1-f6e4-40be-9e68-cf7d43bbd6172025-05-28Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack7b7f5c28-78fa-4625-ad69-4291500e033d2025-05-19Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack51800012-406b-4389-817f-88dd21e338d12025-05-19Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepacka7f75948-2958-44c8-b52f-5e39e80cdd1f2025-05-13Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsbdf02140-3647-498e-ba0a-f4ca920b4e902025-05-01Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
Pravastatin SodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.7abc1825-182d-40bc-9f7f-968e197b42462025-04-30Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions88e3b5b1-8379-492b-8902-af77f87ad9952025-04-25Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepacke358f314-9cbe-46a4-9564-6bedc7ef9d592025-04-23Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack80ddec55-6a18-4b87-8a07-6ae86ad628532025-04-23Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack2290cad1-55c3-45a0-9d50-dd149678d1912025-04-22Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack0bb2f1e8-9405-4f06-9a33-5ba06765a8e72025-04-22Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLC308db0cc-0deb-99b6-e063-6394a90a9b742025-03-17Warnings, Adverse reactionsName fallback
generic name: PRAVASTATIN SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-5178PRAVACHOLPRAVASTATIN SODIUME.R. Squibb & Sons, L.L.C.NDACurrent
0003-5178PRAVACHOLPRAVASTATIN SODIUME.R. Squibb & Sons, L.L.C.NDACurrent
0003-5178PRAVACHOLPRAVASTATIN SODIUME.R. Squibb & Sons, L.L.C.NDACurrent
0003-5194PRAVACHOLPRAVASTATIN SODIUME.R. Squibb & Sons, L.L.C.NDACurrent
0003-5194PRAVACHOLPRAVASTATIN SODIUME.R. Squibb & Sons, L.L.C.NDACurrent
0003-5194PRAVACHOLPRAVASTATIN SODIUME.R. Squibb & Sons, L.L.C.NDACurrent
0003-5195PRAVACHOLPRAVASTATIN SODIUME.R. Squibb & Sons, L.L.C.NDACurrent
0003-5195PRAVACHOLPRAVASTATIN SODIUME.R. Squibb & Sons, L.L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71221SUPPL2022-06-06
71183SUPPL2022-06-01
64726SUPPL2020-09-29
64698SUPPL2020-09-28
11829SUPPL2016-07-08
1788SUPPL2016-07-07
20414SUPPL2013-08-07
34081SUPPL2012-11-06
34080SUPPL2012-11-06
19811SUPPL2012-11-05
19810SUPPL2012-11-05
20415SUPPL2012-03-30
19809SUPPL2012-02-28
11828SUPPL2012-02-28
11827SUPPL2011-05-23
19808SUPPL2011-05-20
41085SUPPL2008-08-08
41087SUPPL2008-08-04
41086SUPPL2008-08-04
20413SUPPL2008-08-04
20412SUPPL2008-08-04
20411SUPPL2008-08-04
41090SUPPL2008-08-01
41080SUPPL2008-02-19
20409SUPPL2008-02-19
20408SUPPL2008-02-19
41089SUPPL2007-11-19
41088SUPPL2007-11-19
41077SUPPL2007-11-19
41081SUPPL2007-04-11
19807SUPPL2007-03-07
11826SUPPL2007-03-07
19806SUPPL2005-07-15
11825SUPPL2005-07-15
19805SUPPL2003-09-25
11824SUPPL2003-09-25
34079SUPPL2002-10-29
1787SUPPL2002-10-29
19804SUPPL2002-07-12
11823SUPPL2002-07-12
34078SUPPL2001-12-18
19803SUPPL2001-12-18
34077SUPPL2001-06-15
19802SUPPL2001-06-15
19801SUPPL2000-06-09
41082SUPPL2000-02-10
1784SUPPL2000-02-10
19800SUPPL2000-01-18
1783SUPPL2000-01-18
1782SUPPL2000-01-18
1781SUPPL2000-01-18
41084SUPPL1999-10-14
41083SUPPL1999-10-14
20410SUPPL1999-10-14
1786SUPPL1999-10-14
1785SUPPL1999-10-14
41079SUPPL1998-03-27
20407SUPPL1998-03-11
41078SUPPL1997-04-15