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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.aa8aed58-691b-472e-8e98-53d0d3f566862026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.7463b093-c2ee-49c3-a08a-e758de66422a2026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.c6b610ab-7367-4e61-9b4a-7ebbd1cf3d362026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepackc03ab80c-a3ae-4634-a76b-f53740db76f52026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
ndc (product): 63629-7421
simvastatinSIMVASTATINNorthwind Health Company, LLCdb0f4c5a-e8e4-3ab1-e053-2995a90a1f9a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNorthwind Health Company, LLCf32d512f-86fa-b70f-e053-2a95a90afd012026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINQPharma, Inc.c80b823c-b30f-0a9d-e053-2995a90a31e92025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINAccord Healthcare, Inc.871251c0-36a1-4a32-9eab-ff6c1e925ca92025-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.56456210-2db5-4f0d-e054-00144ff8d46c2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
ndc (product): 68071-1711
simvastatinSIMVASTATINBryant Ranch Prepackb6d5fb21-a1a8-53e5-80d9-dde0eede5ef52024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
ndc (product): 63629-3408
simvastatinSIMVASTATINBryant Ranch Prepack356ed6a6-e467-4791-87ff-2ae7779fc1b02024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepackce3ac5e8-bdef-d195-e0a0-e1a982008efe2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepack79ca09cd-2396-4e50-b159-1f95671150672024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
ndc (product): 63629-3393
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.54c236ce-69c2-06ef-e054-00144ff88e882024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
ndc (product): 68071-1646
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.54c28733-eb99-10f6-e054-00144ff88e882024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
ndc (product): 68071-3391
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.8ed46bb1-9f84-4418-e053-2a95a90abd4b2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
ndc (product): 68071-4996
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.8e986df7-3020-6755-e053-2995a90aca372024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
ndc (product): 68071-4998
simvastatinSIMVASTATINA-S Medication Solutionsaaeebbc3-2608-41b5-8420-5a2a80316d392023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINProficient Rx LPca760e79-5d8c-4b36-9899-0d37e8e1f24e2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLCb5bebcd0-84e6-410d-af96-63834d262bad2021-04-27Warnings, 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 3 of 4 · 276 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-3393simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-3393simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-3393simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-3408simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-3408simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-3408simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-7421simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-7421simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-7421simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-8130simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-8130simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-8130simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-8131simvastatinsimvastatinBryant Ranch PrepackANDACurrent
63629-8131simvastatinsimvastatinBryant Ranch PrepackANDACurrent
64205-005simvastatinsimvastatinReadyMedsANDACurrent
64205-006simvastatinsimvastatinReadyMedsANDACurrent
67046-669simvastatinsimvastatinContract Pharmacy Services-PAANDACurrent
67046-676simvastatinsimvastatinContract Pharmacy Services-PAANDACurrent
67296-0750simvastatinsimvastatinRedPharm Drug, Inc.ANDACurrent
67296-0750simvastatinsimvastatinRedPharm Drug, Inc.ANDACurrent
67296-0750simvastatinsimvastatinRedPharm Drug, Inc.ANDACurrent
68071-1646simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1646simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1646simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1699simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1711simvastatinsimvastatinNuCare Pharmaceuticals,InANDACurrent
68071-1711simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1711simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1721simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1847simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1868simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1868simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1946simvastatinsimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1946simvastatinsimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1965simvastatinsimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1965simvastatinsimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1965simvastatinsimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1990simvastatinsimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1990simvastatinsimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3090simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3090simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3289simvastatinsimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3289simvastatinsimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3391simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4504simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4504simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4996simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4996simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4996simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4998simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4998simvastatinsimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9429simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9429simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9429simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9429simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9429simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9747simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9747simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9747simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9747simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9747simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9868simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9868simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9868simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9868simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9868simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9869simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9869simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9869simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9869simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9869simvastatinsimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0060simvastatinsimvastatinREMEDYREPACK INC.ANDACurrent
70518-0060simvastatinsimvastatinREMEDYREPACK INC.ANDACurrent
70518-0060simvastatinsimvastatinREMEDYREPACK INC.ANDACurrent
70518-0060simvastatinsimvastatinREMEDYREPACK INC.ANDACurrent
70518-0060simvastatinsimvastatinREMEDYREPACK INC.ANDACurrent
70518-0060simvastatinsimvastatinREMEDYREPACK INC.ANDACurrent
70518-0060simvastatinsimvastatinREMEDYREPACK INC.ANDACurrent
70518-0060simvastatinsimvastatinREMEDYREPACK INC.ANDACurrent
70518-0060simvastatinsimvastatinREMEDYREPACK INC.ANDACurrent

Documents#

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