FDA.reportPublic FDA data

Application 218488

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVEROLIMUSEVEROLIMUSTABLET;ORAL2.5MGNoNo
002EVEROLIMUSEVEROLIMUSTABLET;ORAL5MGNoNo
003EVEROLIMUSEVEROLIMUSTABLET;ORAL7.5MGNoNo
004EVEROLIMUSEVEROLIMUSTABLET;ORAL10MGNoNo

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
A218488-001EVEROLIMUSEVEROLIMUS2.5MGTABLET / ORALAB2026-05-12
A218488-002EVEROLIMUSEVEROLIMUS5MGTABLET / ORALAB2026-05-12
A218488-003EVEROLIMUSEVEROLIMUS7.5MGTABLET / ORALAB2026-05-12
A218488-004EVEROLIMUSEVEROLIMUS10MGTABLET / ORALAB2026-05-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A218488-001AB
A218488-002AB
A218488-003AB
A218488-004AB

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218488-001EVEROLIMUS2.5MGTABLET / ORALAB2026-05-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218488-002EVEROLIMUS5MGTABLET / ORALAB2026-05-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218488-003EVEROLIMUS7.5MGTABLET / ORALAB2026-05-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218488-004EVEROLIMUS10MGTABLET / ORALAB2026-05-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218488-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218488-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218488-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218488-004AB1a50c72e98297…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EverolimusEVEROLIMUS TABLETSBreckenridge Pharmaceutical, Inc.c7bb6ba1-9a7f-43f5-b058-ef26d4b592212026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Everolimus
EverolimusEVEROLIMUSBiocon Pharma Inc.5b809dfe-c076-07c5-207e-178c3f0d32d32026-06-30Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS
EverolimusEVEROLIMUSTeva Pharmaceuticals USA, Inc.e3bca36b-29ed-4a2b-a1be-a57b6af805f62026-06-29Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS
EVEROLIMUSEVEROLIMUSAmneal Pharmaceuticals NY LLC6f1ae129-c21e-4c25-84c1-a6757d9a7eb22026-06-16Warnings, Adverse reactionsName fallback
brand name: EVEROLIMUS
generic name: EVEROLIMUS
TORPENZEVEROLIMUSUpsher-Smith Laboratories, LLC4c0075dd-a0a8-4dc4-be32-1be8383fbbdc2026-06-10Warnings, Adverse reactionsName fallback
generic name: EVEROLIMUS
AfinitorEVEROLIMUSNovartis Pharmaceuticals Corporation2150f73a-179b-4afc-b8ce-67c85cc72f042026-06-01Warnings, Adverse reactionsName fallback
generic name: EVEROLIMUS
YulithiraEVEROLIMUSCivicaScript, LLC5e325efa-8ae6-4dac-b59b-d7c74c73186c2026-03-31Warnings, Adverse reactionsName fallback
generic name: EVEROLIMUS
everolimusEVEROLIMUSNovugen Pharma (USA) LLC.67e62e26-448d-46ec-b5a1-00dc1b5e26c62026-03-10Warnings, Adverse reactionsName fallback
brand name: everolimus
generic name: EVEROLIMUS
everolimusEVEROLIMUSAurobindo Pharma Limited43ef3c29-0e25-4fdd-aea1-06a20af9bbab2026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: everolimus
generic name: EVEROLIMUS
ZortressEVEROLIMUSNovartis Pharmaceuticals Corporatione082a024-7850-400b-a5c2-2a140612562a2026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: EVEROLIMUS
EverolimusEVEROLIMUSAscend Laboratories, LLC2693c497-a70b-4d00-b6db-602c872e5bed2025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS
EverolimusEVEROLIMUSNatco Pharma Limitedd44998bb-5deb-4ee7-a0a5-979fe3f495572025-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS
EverolimusEVEROLIMUSBreckenridge Pharmaceutical, Inc.01f7b5fb-be0d-4adf-acd2-6899018de9662025-09-05Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS
EverolimusEVEROLIMUSBiocon Pharma Inc.435da284-ef0e-ca90-e0db-bab9382922e02025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS
EVEROLIMUSEVEROLIMUSBiocon Pharma Inc.5fb55800-f322-6bb6-9dde-622925ef28bd2025-03-21Warnings, Adverse reactionsName fallback
brand name: EVEROLIMUS
generic name: EVEROLIMUS
EverolimusEVEROLIMUSPar Health USA, LLC59cb86d5-8706-4619-b074-af253d3e0b682025-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS
EverolimusEVEROLIMUSHikma Pharmaceuticals USA Inc.cf2dd54b-7a1d-4401-9a01-75e68235e4332024-09-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS
EVEROLIMUSEVEROLIMUSNorthStar RxLLC5cfca904-b75c-5a39-8cb9-b99bb421bceb2024-08-02Warnings, Adverse reactionsName fallback
brand name: EVEROLIMUS
generic name: EVEROLIMUS
EverolimusEVEROLIMUSHikma Pharmaceuticals USA Inc.5aaf2fb7-93f6-40d6-941a-9583a3794ce72024-04-23Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS
EverolimusEVEROLIMUSNatco Pharma Limitede3dbbc24-7e55-4069-a305-e2cded2db6412023-06-08Warnings, Adverse reactionsName fallback
brand name: Everolimus
generic name: EVEROLIMUS