FDA.reportPublic FDA data

Application 076052

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

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

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
A076052-001SIMVASTATINSIMVASTATIN5MGTABLET / ORAL2006-06-23
A076052-002SIMVASTATINSIMVASTATIN10MGTABLET / ORAL2006-06-23
A076052-003SIMVASTATINSIMVASTATIN20MGTABLET / ORAL2006-06-23
A076052-004SIMVASTATINSIMVASTATIN40MGTABLET / ORAL2006-06-23
A076052-005SIMVASTATINSIMVASTATIN80MGTABLET / ORAL2006-12-20

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 22:38:342026-08A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-2384e616aacf4f…
2026-09-14 22:38:342026-08A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-2084e616aacf4f…
2026-08-18 06:07:402026-07A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-2003ed91905a0d…

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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLCc0a303c5-6277-47ce-bb8a-bd5400fd82612023-03-20Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINA-S Medication Solutionsd09f88b5-b95f-4315-9b75-c09ce3d943972023-03-13Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINProficient Rx LPb5b47d5b-f953-4e82-99ef-e4e10164095e2023-03-01Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
simvastatinSIMVASTATINA-S Medication Solutionsaaeebbc3-2608-41b5-8420-5a2a80316d392023-02-04Warnings, Adverse reactionsName fallback
brand name: simvastatin
generic name: SIMVASTATIN
SIMVASTATINSIMVASTATINNCS HealthCare of KY, LLC dba Vangard Labs8850724a-a431-46e5-b88e-1d77b0b62d6e2022-09-26Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
simvastatinSIMVASTATINProficient Rx LPca760e79-5d8c-4b36-9899-0d37e8e1f24e2022-05-01Warnings, Adverse reactionsName fallback
brand name: simvastatin
generic name: SIMVASTATIN
SIMVASTATINSIMVASTATINProficient Rx LP7649bec7-04c6-47b5-a050-15923006dac02022-04-01Warnings, Adverse reactionsName fallback
brand name: SIMVASTATIN
generic name: SIMVASTATIN
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLCa753846e-4cd5-4ddc-a4f2-c45da571c8832021-12-23Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC37860f3f-984e-419a-a262-3bacc766953e2021-12-13Warnings, Adverse reactionsName fallback
brand name: Simvastatin
generic name: SIMVASTATIN
simvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLCb5bebcd0-84e6-410d-af96-63834d262bad2021-04-27Warnings, Adverse reactionsName fallback
brand name: simvastatin
generic name: SIMVASTATIN
simvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC121b0e00-abb7-4e07-a7b2-311be89fabb72019-03-25Warnings, Adverse reactionsName fallback
brand name: simvastatin
generic name: SIMVASTATIN

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 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7152SimvastatinSimvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7152SimvastatinSimvastatinTeva Pharmaceuticals USA,ANDACurrent
0093-7153SimvastatinSimvastatinTeva Pharmaceuticals USA,ANDACurrent
0093-7153SimvastatinSimvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7153SimvastatinSimvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7154SimvastatinSimvastatinTeva Pharmaceuticals USA,ANDACurrent
0093-7154SimvastatinSimvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7154SimvastatinSimvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7155SimvastatinSimvastatinTeva Pharmaceuticals USA,ANDACurrent
0093-7155SimvastatinSimvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7155SimvastatinSimvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7156SimvastatinSimvastatinTeva Pharmaceuticals USA,ANDACurrent
0093-7156SimvastatinSimvastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0179-0128SimvastatinSimvastatinKAISER FOUNDATION HOSPITALSANDACurrent
0179-1897SimvastatinSimvastatinKAISER FOUNDATION HOSPITALSANDACurrent
0179-1898SimvastatinSimvastatinKAISER FOUNDATION HOSPITALSANDACurrent
0179-1899SimvastatinSimvastatinKAISER FOUNDATION HOSPITALSANDACurrent
42708-051SimvastatinSimvastatinQPharma IncANDACurrent
42708-051SimvastatinSimvastatinQPharma IncANDACurrent
42708-052SimvastatinSimvastatinQPharma IncANDACurrent
42708-052SimvastatinSimvastatinQPharma IncANDACurrent
51079-454SimvastatinSimvastatinMylan Institutional Inc.ANDACurrent
51079-454SimvastatinSimvastatinMylan Institutional Inc.ANDACurrent
51079-455SimvastatinSimvastatinMylan Institutional Inc.ANDACurrent
51079-455SimvastatinSimvastatinMylan Institutional Inc.ANDACurrent
51079-456SimvastatinSimvastatinMylan Institutional Inc.ANDACurrent
51079-456SimvastatinSimvastatinMylan Institutional Inc.ANDACurrent
53808-0792SimvastatinSimvastatinState of Florida DOH Central PharmacyANDACurrent
54458-932SimvastatinSimvastatinInternational Laboratories, LLCANDACurrent
54458-932SimvastatinSimvastatinInternational Laboratories, LLCANDACurrent
54458-933SimvastatinSimvastatinInternational Laboratories, LLCANDACurrent
54458-933SimvastatinSimvastatinInternational Laboratories, LLCANDACurrent
54458-934SimvastatinSimvastatinInternational Laboratories, LLCANDACurrent
54458-934SimvastatinSimvastatinInternational Laboratories, LLCANDACurrent
55289-293SimvastatinSimvastatinPD-Rx Pharmaceuticals, InANDACurrent
55289-293SimvastatinSimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-338SimvastatinSimvastatinPD-Rx Pharmaceuticals, InANDACurrent
55289-338SimvastatinSimvastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
66116-316SimvastatinSimvastatinMedVantx, Inc.ANDACurrent
68071-3157SimvastatinSimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68151-0177SimvastatinSimvastatinCarilion Materials ManagementANDACurrent
68788-7437SimvastatinSimvastatinPreferred Pharmaceuticals, Inc.ANDACurrent
71205-070SimvastatinSimvastatinProficient Rx LPANDACurrent
71205-070SimvastatinSimvastatinProficient Rx LPANDACurrent
71335-1020SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
71335-1020SimvastatinSimvastatinBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23796ORIG2011-05-26
31066ORIG2006-06-27