Application 076341

Type
ANDA
Sponsor
APOTEX

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 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
A076341-001PRAVASTATIN SODIUMPRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23
A076341-002PRAVASTATIN SODIUMPRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23
A076341-003PRAVASTATIN SODIUMPRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23
A076341-004PRAVASTATIN SODIUMPRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076341-001AB
A076341-002AB
A076341-003AB
A076341-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-2384e616aacf4f…
2026-09-14 22:38:342026-08A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-2384e616aacf4f…
2026-09-14 22:38:342026-08A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-2384e616aacf4f…
2026-09-14 22:38:342026-08A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-2884e616aacf4f…
2026-08-18 06:07:402026-07A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-001PRAVASTATIN SODIUM10MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-002PRAVASTATIN SODIUM20MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-003PRAVASTATIN SODIUM40MGTABLET / ORALAB2006-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-004PRAVASTATIN SODIUM80MGTABLET / ORALAB2007-12-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076341-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076341-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076341-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A076341-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A076341-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076341-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076341-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076341-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076341-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076341-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076341-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076341-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076341-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076341-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076341-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076341-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076341-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076341-004AB15bbf6a4d5a75…

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.5ecd9fd1-7662-412d-99c5-13c77188748c2026-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.e4dbaa72-7b3e-4aef-983b-90efb2b343cd2026-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.6d42bd30-1f09-49f4-9ec8-31366df1b4b42026-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.46cdd32d-a022-4acf-ba2b-10e7877d56c62026-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc..ebd794ba-90c3-4d81-9c45-4aa9d94543592026-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC3e218ad6-5b47-4cca-81be-ebaea57959642026-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallente9c188f7-cd6f-afac-b493-36552d86589e2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
ndc (product): 82009-007
ndc (product): 82009-006
ndc (product): 82009-008
PRAVASTATIN SODIUMPRAVASTATIN SODIUMApotex Corp.dcf45e4f-b46e-6fbb-b67a-2ff619ab17802026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.c5f611aa-9974-422e-a353-5d834a33937c2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
ndc (product): 72789-143
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.8dbdc80d-9d8c-4e22-9108-d87a77e07a6b2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
ndc (product): 72789-161
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC9289f9ed-b6e3-4e81-bdb8-6aedbd5288a92026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack14390bfa-3bcb-43e1-936c-1977cb37427d2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack8d1bf7a5-bf11-47e3-afca-dcc13f2d30682026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNorthwind Health Company, LLC4fad5d73-aa79-58f2-e063-6294a90af4aa2026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions93b0e546-9e0f-40d1-9b1e-082bf16400a42026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutionsd69e8af8-dbd4-43d9-8e9a-4aed3923a17c2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackf4b330ce-dfb0-4e4e-9f37-482458820c662026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNCS HealthCare of KY, LLC dba Vangard Labs64ccb4b5-b77e-4b23-8c74-4685287edb4b2026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackc0b1b483-1a19-4966-89b1-118ec660f2032026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAvPAKba4ac602-46fa-8386-e053-2995a90a97642026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076341
application number: ANDA076341

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 3 of 3 · 192 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71335-1243PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
71335-1243PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
71335-1243PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
71335-1631PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch PrepackANDACurrent
71610-637PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-059PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72189-059PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72189-059PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72189-060PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72189-060PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72189-060PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72189-061PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72189-061PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72189-061PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72189-119PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
72789-143PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-143PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-143PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-143PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-161PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-161PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-161PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-161PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
82009-006PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallentANDACurrent
82009-006PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallentANDACurrent
82009-006PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallentANDACurrent
82009-007PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallentANDACurrent
82009-007PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallentANDACurrent
82009-007PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallentANDACurrent
82009-008PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallentANDACurrent
82009-008PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallentANDACurrent
82009-008PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallentANDACurrent