FDA.reportPublic FDA data

Application 206084

Type
ANDA
Sponsor
SCOV3

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBE AND ATORVASTATIN CALCIUMATORVASTATIN CALCIUM; EZETIMIBETABLET;ORALEQ 10MG BASE;10MGNoNo
002EZETIMIBE AND ATORVASTATIN CALCIUMATORVASTATIN CALCIUM; EZETIMIBETABLET;ORALEQ 20MG BASE;10MGNoNo
003EZETIMIBE AND ATORVASTATIN CALCIUMATORVASTATIN CALCIUM; EZETIMIBETABLET;ORALEQ 40MG BASE;10MGNoNo
004EZETIMIBE AND ATORVASTATIN CALCIUMATORVASTATIN CALCIUM; EZETIMIBETABLET;ORALEQ 80MG BASE;10MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A206084-001LYPQOZETATORVASTATIN CALCIUM; EZETIMIBEEQ 10MG BASE;10MGTABLET / ORAL2017-04-26
A206084-002LYPQOZETATORVASTATIN CALCIUM; EZETIMIBEEQ 20MG BASE;10MGTABLET / ORAL2017-04-26
A206084-003LYPQOZETATORVASTATIN CALCIUM; EZETIMIBEEQ 40MG BASE;10MGTABLET / ORAL2017-04-26
A206084-004LYPQOZETATORVASTATIN CALCIUM; EZETIMIBEEQ 80MG BASE;10MGTABLET / 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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206084-001LYPQOZETEQ 10MG BASE;10MGTABLET / ORAL2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206084-002LYPQOZETEQ 20MG BASE;10MGTABLET / ORAL2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206084-003LYPQOZETEQ 40MG BASE;10MGTABLET / ORAL2017-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206084-004LYPQOZETEQ 80MG BASE;10MGTABLET / ORALRS2017-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206084-001LYPQOZETEQ 10MG BASE;10MGTABLET / ORAL2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206084-002LYPQOZETEQ 20MG BASE;10MGTABLET / ORAL2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206084-003LYPQOZETEQ 40MG BASE;10MGTABLET / ORAL2017-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206084-004LYPQOZETEQ 80MG BASE;10MGTABLET / ORALRS2017-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206084-001LYPQOZETEQ 10MG BASE;10MGTABLET / ORAL2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A206084-002LYPQOZETEQ 20MG BASE;10MGTABLET / ORAL2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A206084-003LYPQOZETEQ 40MG BASE;10MGTABLET / ORAL2017-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A206084-004LYPQOZETEQ 80MG BASE;10MGTABLET / ORALRS2017-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206084-001LYPQOZETEQ 10MG BASE;10MGTABLET / ORAL2017-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206084-002LYPQOZETEQ 20MG BASE;10MGTABLET / ORAL2017-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206084-003LYPQOZETEQ 40MG BASE;10MGTABLET / ORAL2017-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206084-004LYPQOZETEQ 80MG BASE;10MGTABLET / ORALRS2017-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206084-001LYPQOZETEQ 10MG BASE;10MGTABLET / ORAL2017-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206084-002LYPQOZETEQ 20MG BASE;10MGTABLET / ORAL2017-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206084-003LYPQOZETEQ 40MG BASE;10MGTABLET / ORAL2017-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206084-004LYPQOZETEQ 80MG BASE;10MGTABLET / ORALRS2017-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206084-001LYPQOZETEQ 10MG BASE;10MGTABLET / ORAL2017-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206084-002LYPQOZETEQ 20MG BASE;10MGTABLET / ORAL2017-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206084-003LYPQOZETEQ 40MG BASE;10MGTABLET / ORAL2017-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206084-004LYPQOZETEQ 80MG BASE;10MGTABLET / ORALRS2017-04-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206084-001LYPQOZETEQ 10MG BASE;10MGTABLET / ORAL2017-04-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206084-002LYPQOZETEQ 20MG BASE;10MGTABLET / ORAL2017-04-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206084-003LYPQOZETEQ 40MG BASE;10MGTABLET / ORAL2017-04-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206084-004LYPQOZETEQ 80MG BASE;10MGTABLET / ORALRS2017-04-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206084-001EZETIMIBE AND ATORVASTATIN CALCIUMEQ 10MG BASE;10MGTABLET / ORAL2017-04-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206084-002EZETIMIBE AND ATORVASTATIN CALCIUMEQ 20MG BASE;10MGTABLET / ORAL2017-04-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206084-003EZETIMIBE AND ATORVASTATIN CALCIUMEQ 40MG BASE;10MGTABLET / ORAL2017-04-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206084-004EZETIMIBE AND ATORVASTATIN CALCIUMEQ 80MG BASE;10MGTABLET / ORAL2017-04-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206084-001EZETIMIBE AND ATORVASTATIN CALCIUMEQ 10MG BASE;10MGTABLET / ORAL2017-04-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206084-002EZETIMIBE AND ATORVASTATIN CALCIUMEQ 20MG BASE;10MGTABLET / ORAL2017-04-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206084-003EZETIMIBE AND ATORVASTATIN CALCIUMEQ 40MG BASE;10MGTABLET / ORAL2017-04-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206084-004EZETIMIBE AND ATORVASTATIN CALCIUMEQ 80MG BASE;10MGTABLET / ORAL2017-04-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206084-001EZETIMIBE AND ATORVASTATIN CALCIUMEQ 10MG BASE;10MGTABLET / ORAL2017-04-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206084-002EZETIMIBE AND ATORVASTATIN CALCIUMEQ 20MG BASE;10MGTABLET / ORAL2017-04-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206084-003EZETIMIBE AND ATORVASTATIN CALCIUMEQ 40MG BASE;10MGTABLET / ORAL2017-04-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206084-004EZETIMIBE AND ATORVASTATIN CALCIUMEQ 80MG BASE;10MGTABLET / ORAL2017-04-264b0b4de00fa7…

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70661-005LYPQOZET(ezetimibe and atorvastatin)Althera Pharmaceuticals, LLCANDACurrent
70661-006LYPQOZET(ezetimibe and atorvastatin)Althera Pharmaceuticals, LLCANDACurrent
70661-007LYPQOZET(ezetimibe and atorvastatin)Althera Pharmaceuticals, LLCANDACurrent
70661-008LYPQOZET(ezetimibe and atorvastatin)Althera Pharmaceuticals, LLCANDACurrent
82120-125ROSUVASTATIN AND EZETIMIBErosuvastatin and ezetimibeSCOV3 LLCANDACurrent
82120-126ROSUVASTATIN AND EZETIMIBErosuvastatin and ezetimibeSCOV3 LLCANDACurrent
82120-127ROSUVASTATIN AND EZETIMIBErosuvastatin and ezetimibeSCOV3 LLCANDACurrent
82120-128ROSUVASTATIN AND EZETIMIBErosuvastatin and ezetimibeSCOV3 LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48206ORIG2017-05-02