Application 209869

Type
ANDA
Sponsor
CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL10MGNoNo
002PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL20MGNoNo
003PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL40MGNoNo
004PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL80MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209869-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13
A209869-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13
A209869-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13
A209869-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A209869-001AB
A209869-002AB
A209869-003AB
A209869-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2018-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2018-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2018-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2018-04-13d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209869-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209869-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209869-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209869-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209869-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209869-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209869-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209869-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209869-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209869-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209869-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209869-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209869-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209869-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209869-004AB1d8e5a09893c0…

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 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackca7a4143-0091-4cd5-9061-cb05cc84ea4e2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepackf074240e-ef6b-45f2-8c4d-cb5c0dbc81f12026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack3686a2df-51c4-4f1c-9d1e-d692079151442026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackd0641def-425e-4357-a6b6-24ce004245492026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
ndc (product): 63629-9163
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackdcf46d0c-87da-4009-b238-eb5cf287c3ed2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
ndc (product): 63629-8911
Pravastatin sodiumPRAVASTATIN SODIUMGolden State Medical Supply, Inc.25b7276e-a69f-af63-e063-6394a90aecf22026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBiocon Pharma Inc.9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
ndc (product): 70377-047
ndc (product): 70377-045
ndc (product): 70377-046
ndc (product): 70377-048
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions2f658680-939a-4212-8a5e-a44a896dd2212026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions3b9fe7c9-791e-49a0-a005-ccf13036c3652026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC40aa2d36-57ce-1f48-e063-6294a90affef2026-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC47207487-0c6d-8da3-e063-6294a90a8aee2025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack4ed7a4d1-1183-4d95-8311-6d3e58feafa82025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions33c141e9-76dc-4e32-9b2a-4621f32ac4bd2025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions72693449-01ee-42b0-9902-5662523245792025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack7b7f5c28-78fa-4625-ad69-4291500e033d2025-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack51800012-406b-4389-817f-88dd21e338d12025-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepacka7f75948-2958-44c8-b52f-5e39e80cdd1f2025-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepacke358f314-9cbe-46a4-9564-6bedc7ef9d592025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
ndc (product): 63629-8910
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack80ddec55-6a18-4b87-8a07-6ae86ad628532025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209869
application number: ANDA209869
ndc (product): 63629-8913

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55801-141PRAVASTATIN SODIUMPRAVASTATIN SODIUMAPPCO PHARMA LLCANDACurrent
55801-142PRAVASTATIN SODIUMPRAVASTATIN SODIUMAPPCO PHARMA LLCANDACurrent
55801-143PRAVASTATIN SODIUMPRAVASTATIN SODIUMAPPCO PHARMA LLCANDACurrent
55801-144PRAVASTATIN SODIUMPRAVASTATIN SODIUMAPPCO PHARMA LLCANDACurrent
63629-8904PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8904PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8905PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8905PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8906PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8906PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8909PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8909PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8910PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8910PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8911PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8911PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8912PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8912PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8913PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-8913PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-9162PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-9162PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-9163PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-9163PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-9164PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-9164PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-9165PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
63629-9165PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
70377-045PRAVASTATIN SODIUMPRAVASTATIN SODIUMBIOCON PHARMA INC.,ANDACurrent
70377-045PRAVASTATIN SODIUMPRAVASTATIN SODIUMBIOCON PHARMA INC.,ANDACurrent
70377-046PRAVASTATIN SODIUMPRAVASTATIN SODIUMBIOCON PHARMA INC.,ANDACurrent
70377-046PRAVASTATIN SODIUMPRAVASTATIN SODIUMBIOCON PHARMA INC.,ANDACurrent
70377-047PRAVASTATIN SODIUMPRAVASTATIN SODIUMBIOCON PHARMA INC.,ANDACurrent
70377-047PRAVASTATIN SODIUMPRAVASTATIN SODIUMBIOCON PHARMA INC.,ANDACurrent
70377-048PRAVASTATIN SODIUMPRAVASTATIN SODIUMBIOCON PHARMA INC.,ANDACurrent
70377-048PRAVASTATIN SODIUMPRAVASTATIN SODIUMBIOCON PHARMA INC.,ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53693ORIG2018-04-16