FDA.reportPublic FDA data

Application 078155

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIMVASTATINSIMVASTATINTABLET;ORAL80MGNoNo
002SIMVASTATINSIMVASTATINTABLET;ORAL10MGNoNo
003SIMVASTATINSIMVASTATINTABLET;ORAL20MGNoNo
004SIMVASTATINSIMVASTATINTABLET;ORAL40MGNoNo
005SIMVASTATINSIMVASTATINTABLET;ORAL5MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078155-001SIMVASTATINSIMVASTATIN80MGTABLET / ORALAB2008-02-26
A078155-002SIMVASTATINSIMVASTATIN10MGTABLET / ORALAB2008-02-26
A078155-003SIMVASTATINSIMVASTATIN20MGTABLET / ORALAB2008-02-26
A078155-004SIMVASTATINSIMVASTATIN40MGTABLET / ORALAB2008-02-26
A078155-005SIMVASTATINSIMVASTATIN5MGTABLET / ORALAB2013-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A078155-001AB
A078155-002AB
A078155-003AB
A078155-004AB
A078155-005AB

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-2684e616aacf4f…
2026-09-14 22:38:342026-08A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-2684e616aacf4f…
2026-09-14 22:38:342026-08A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-2684e616aacf4f…
2026-09-14 22:38:342026-08A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-2684e616aacf4f…
2026-09-14 22:38:342026-08A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-0584e616aacf4f…
2026-08-18 06:07:402026-07A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-0503ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078155-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078155-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078155-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078155-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078155-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A078155-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078155-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078155-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078155-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078155-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078155-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078155-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-005AB103ed91905a0d…

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
simvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC121b0e00-abb7-4e07-a7b2-311be89fabb72019-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155

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 4 · 276 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0240simvastatinsimvastatinKAISER FOUNDATION HOSPITALSANDACurrent
0179-0241simvastatinsimvastatinKAISER FOUNDATION HOSPITALSANDACurrent
0179-0242simvastatinsimvastatinKAISER FOUNDATION HOSPITALSANDACurrent
0179-0243simvastatinsimvastatinKAISER FOUNDATION HOSPITALSANDACurrent
10544-907simvastatinsimvastatinBlenheim Pharmacal, Inc.ANDACurrent
10544-908simvastatinsimvastatinBlenheim Pharmacal, Inc.ANDACurrent
16729-004simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-004simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-004simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-004simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-004simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-004simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-005simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-005simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-005simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-005simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-005simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-005simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-006simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-006simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-006simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-006simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-006simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-006simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-007simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-007simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-007simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-007simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-007simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-007simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-156simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-156simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-156simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-156simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-156simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
16729-156simvastatinsimvastatinAccord Healthcare, Inc.ANDACurrent
33261-541simvastatinsimvastatinAidarex Pharmaceuticals LLCANDACurrent
33261-542simvastatinsimvastatinAidarex Pharmaceuticals LLCANDACurrent
33261-546simvastatinsimvastatinAidarex Pharmaceuticals LLCANDACurrent
33358-431simvastatinsimvastatinRxChange Co.ANDACurrent
33358-475simvastatinsimvastatinRxChange Co.ANDACurrent
42254-032simvastatinsimvastatinRebel Distributors CorpANDACurrent
42254-060simvastatinsimvastatinRebel Distributors CorpANDACurrent
42254-129simvastatinsimvastatinRebel Distributors CorpANDACurrent
42254-168simvastatinsimvastatinRebel Distributors CorpANDACurrent
42708-148simvastatinsimvastatinQPharma IncANDACurrent
43063-008simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-008simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-008simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-008simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-008simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-008simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-008simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-008simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-726simvastatinsimvastatinPD-Rx Pharmaceuticals, InANDACurrent
43063-726simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-726simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-726simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-726simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-726simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-726simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-727simvastatinsimvastatinPD-Rx Pharmaceuticals, InANDACurrent
43063-727simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-727simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-727simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-727simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-727simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-727simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-733simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-733simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-733simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-733simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-733simvastatinsimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-664simvastatinsimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-664simvastatinsimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0999simvastatinsimvastatinA-S Medication SolutionsANDACurrent
50090-0999simvastatinsimvastatinA-S Medication SolutionsANDACurrent
50090-0999simvastatinsimvastatinA-S Medication SolutionsANDACurrent
50090-0999simvastatinsimvastatinA-S Medication SolutionsANDACurrent
50090-1000simvastatinsimvastatinA-S Medication SolutionsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23897ORIG2008-02-28