FDA.reportPublic FDA data

Application 202968

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;10MGNoNo
002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;20MGNoNo
003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;40MGNoNo
004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;80MGNoNo

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202968-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORAL2017-04-26a50c72e98297…
2026-08-01 22:54:322026-06A202968-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORAL2017-04-26a50c72e98297…
2026-08-01 22:54:322026-06A202968-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORAL2017-04-26a50c72e98297…
2026-08-01 22:54:322026-06A202968-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORAL2017-04-26a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINA-S Medication Solutions2ce219a2-1eeb-4ece-bb87-3810e593ca512026-02-06Warnings, Adverse reactionsName fallback
brand name: Ezetimibe and Simvastatin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINGolden State Medical Supply, Inc.88cd0e7b-e8dc-6125-e053-2a95a90aaa272025-11-24Warnings, Adverse reactionsName fallback
brand name: Ezetimibe and Simvastatin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINDr.Reddys Laboratories Inc023ca87a-1b04-8c17-dc4f-e2758b0771e22025-07-18Warnings, Adverse reactionsName fallback
brand name: Ezetimibe and Simvastatin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAscend Laboratories, LLCc90e8c96-e130-42d7-bf0d-5833652e40d52025-05-02Warnings, Adverse reactionsName fallback
brand name: Ezetimibe and Simvastatin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAmneal Pharmaceuticals NY LLC5ea3ca31-cfee-4978-8b7a-755986f6b0912025-01-30Warnings, Adverse reactionsName fallback
brand name: Ezetimibe and Simvastatin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAurobindo Pharma Limited79dadfde-35c7-4937-9c82-1728fb6be2fb2024-10-22Warnings, Adverse reactionsName fallback
brand name: Ezetimibe and Simvastatin
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINNORTHSTAR RX LLC52a46269-2262-4052-a3ff-5455523f591f2024-09-27Warnings, Adverse reactionsName fallback
brand name: ezetimibe and simvastatin
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINGlenmark Pharmaceuticals Inc., USA32d0e130-1211-44ca-be60-5379ffec96fd2024-04-30Warnings, Adverse reactionsName fallback
brand name: ezetimibe and simvastatin
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINA-S Medication Solutions2c936363-b483-46c6-936c-a07d8ab0280c2024-01-16Warnings, Adverse reactionsName fallback
brand name: ezetimibe and simvastatin

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45963-565Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-565Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-565Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-565Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-565Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-565Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-565Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-565Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-566Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-566Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-566Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-566Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-566Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-566Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-566Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-566Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-567Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-567Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-567Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-567Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-567Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-567Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-567Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-567Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-568Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-568Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-568Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-568Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-568Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-568Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-568Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
45963-568Ezetimibe and SimvastatinEzetimibe and SimvastatinActavis Pharma, Inc.ANDACurrent
50090-3479Ezetimibe and SimvastatinEzetimibe and SimvastatinA-S Medication SolutionsANDACurrent
50090-3486Ezetimibe and SimvastatinEzetimibe and SimvastatinA-S Medication SolutionsANDACurrent