FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
50090-3486
11-digit product format
500903486
Labeler code
50090
Product ID
50090-3486_49f50632-821c-4f64-942d-218b52a5560a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202968
Marketing category
ANDA
Marketing start
2017-04-26
Marketing end
0000-00-00
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3486DDiscontinued by firm2026-08-03
excluded packagepackage50090-348650090-3486-0DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202968-001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-26
A202968-002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-26
A202968-003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-26
A202968-004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-26

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2017-04-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2017-04-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2017-04-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2017-04-2674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A202968-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A202968-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A202968-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A202968-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202968-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202968-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202968-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202968-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202968-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202968-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202968-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202968-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202968-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202968-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202968-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202968-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202968-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202968-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202968-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202968-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202968-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202968-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202968-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202968-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202968-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202968-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202968-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202968-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202968-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202968-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202968-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202968-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202968-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202968-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202968-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202968-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202968-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202968-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202968-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202968-004AB174a2ff9319b5…