FDA.reportPublic FDA data

Application 202079

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL4MGNoNo
002CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL8MGNoNo
003CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL16MGNoNo
004CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL32MGNoNo

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
A202079-001CANDESARTAN CILEXETILCANDESARTAN CILEXETIL4MGTABLET / ORAL2014-01-10
A202079-002CANDESARTAN CILEXETILCANDESARTAN CILEXETIL8MGTABLET / ORAL2014-01-10
A202079-003CANDESARTAN CILEXETILCANDESARTAN CILEXETIL16MGTABLET / ORAL2014-01-10
A202079-004CANDESARTAN CILEXETILCANDESARTAN CILEXETIL32MGTABLET / ORAL2014-01-10

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 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A202079-001CANDESARTAN CILEXETIL4MGTABLET / ORAL2014-01-10f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A202079-002CANDESARTAN CILEXETIL8MGTABLET / ORAL2014-01-10f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A202079-003CANDESARTAN CILEXETIL16MGTABLET / ORAL2014-01-10f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A202079-004CANDESARTAN CILEXETIL32MGTABLET / ORAL2014-01-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202079-001CANDESARTAN CILEXETIL4MGTABLET / ORAL2014-01-10e64feba35796…
2022-09-29 23:25 UTC2022-09A202079-002CANDESARTAN CILEXETIL8MGTABLET / ORAL2014-01-10e64feba35796…
2022-09-29 23:25 UTC2022-09A202079-003CANDESARTAN CILEXETIL16MGTABLET / ORAL2014-01-10e64feba35796…
2022-09-29 23:25 UTC2022-09A202079-004CANDESARTAN CILEXETIL32MGTABLET / ORAL2014-01-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202079-001CANDESARTAN CILEXETIL4MGTABLET / ORAL2014-01-10cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202079-002CANDESARTAN CILEXETIL8MGTABLET / ORAL2014-01-10cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202079-003CANDESARTAN CILEXETIL16MGTABLET / ORAL2014-01-10cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202079-004CANDESARTAN CILEXETIL32MGTABLET / ORAL2014-01-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202079-001CANDESARTAN CILEXETIL4MGTABLET / ORAL2014-01-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202079-002CANDESARTAN CILEXETIL8MGTABLET / ORAL2014-01-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202079-003CANDESARTAN CILEXETIL16MGTABLET / ORAL2014-01-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202079-004CANDESARTAN CILEXETIL32MGTABLET / ORAL2014-01-10a50c72e98297…

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candesartan cilexetilCANDESARTAN CILEXETILViona Pharmaceuticals Inc9da86c48-5911-4512-8c71-eca4a6418cf62026-09-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Candesartan cilexetil
generic name: CANDESARTAN CILEXETIL
Candesartan cilexetilCANDESARTAN CILEXETILGolden State Medical Supply, Inc.15601654-76da-04cf-e063-6394a90a2cb52026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Candesartan cilexetil
generic name: CANDESARTAN CILEXETIL
Candesartan cilexetilCANDESARTAN CILEXETILZydus Lifesciences Limited26df3269-3682-4ce0-be81-8c029254b5a82025-12-24Name fallback
brand name: Candesartan cilexetil
generic name: CANDESARTAN CILEXETIL
ATACANDCANDESARTAN CILEXETILANI Pharmaceuticals, Inc.94a59260-d2b6-464a-b5b9-bbc599e57e102025-12-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CANDESARTAN CILEXETIL
Candesartan cilexetilCANDESARTAN CILEXETILANI Pharmaceuticals, Inc.4621249c-1f44-4d95-8513-a1a2b1859e412025-12-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Candesartan cilexetil
generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETILCANDESARTAN CILEXETILBryant Ranch Prepack9afc130e-a784-49fe-9772-27c492724f082023-09-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CANDESARTAN CILEXETIL
generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETILCANDESARTAN CILEXETILAlembic Pharmaceuticals Limitedd5b43fa0-6678-4219-99f1-10d273d49baf2023-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CANDESARTAN CILEXETIL
generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETILCANDESARTAN CILEXETILAlembic Pharmaceuticals Limitedd23fe59a-2ad6-4885-a0d8-2239048f05a32023-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CANDESARTAN CILEXETIL
generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETILCANDESARTAN CILEXETILAlembic Pharmaceuticals Inc.0f2b2fa3-249b-4756-a3f1-3223a004d9cb2021-10-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CANDESARTAN CILEXETIL
generic name: CANDESARTAN CILEXETIL
CANDESARTAN CILEXETILCANDESARTAN CILEXETILAlembic Pharmaceuticals Inc.8a515af5-bd53-43f1-b40a-aa0f332bc2ab2021-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CANDESARTAN CILEXETIL
generic name: CANDESARTAN CILEXETIL
candesartan cilexetilCANDESARTAN CILEXETILMylan Pharmaceuticals Inc.904b357e-97bf-475e-90a5-f0449f2a428e2021-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: candesartan cilexetil
generic name: CANDESARTAN CILEXETIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.