FDA.reportPublic FDA data

Application 211660

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEFERASIROXDEFERASIROXTABLET;ORAL90MGNoNo
002DEFERASIROXDEFERASIROXTABLET;ORAL180MGNoNo
003DEFERASIROXDEFERASIROXTABLET;ORAL360MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211660-001DEFERASIROXDEFERASIROX90MGTABLET / ORALAB2025-04-11
A211660-002DEFERASIROXDEFERASIROX180MGTABLET / ORALAB2025-04-11
A211660-003DEFERASIROXDEFERASIROX360MGTABLET / ORALAB2025-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211660-001AB
A211660-002AB
A211660-003AB

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
2026-02-19 14:30 UTC2026-02A211660-001DEFERASIROX90MGTABLET / ORALAB2025-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211660-002DEFERASIROX180MGTABLET / ORALAB2025-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211660-003DEFERASIROX360MGTABLET / ORALAB2025-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211660-001DEFERASIROX90MGTABLET / ORALAB2025-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211660-002DEFERASIROX180MGTABLET / ORALAB2025-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211660-003DEFERASIROX360MGTABLET / ORALAB2025-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211660-001DEFERASIROX90MGTABLET / ORALAB2025-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211660-002DEFERASIROX180MGTABLET / ORALAB2025-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211660-003DEFERASIROX360MGTABLET / ORALAB2025-04-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211660-001DEFERASIROX90MGTABLET / ORALAB2025-04-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211660-002DEFERASIROX180MGTABLET / ORALAB2025-04-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211660-003DEFERASIROX360MGTABLET / ORALAB2025-04-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211660-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211660-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211660-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211660-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211660-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211660-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211660-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211660-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211660-003AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211660-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211660-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211660-003AB1a50c72e98297…

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ExjadeDEFERASIROXNovartis Pharmaceuticals Corporation3495a70c-870c-4968-940e-8baea152cf852026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DEFERASIROX
DeferasiroxDEFERASIROXAvKARE485c4834-7bec-2018-e063-6294a90ab4e32026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
DeferasiroxDEFERASIROXNovadoz Pharmaceuticals LLCa03c7657-fdca-4acb-ad82-c24680e90eae2025-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
JadenuDEFERASIROXNovartis Pharmaceuticals Corporationfee89140-fff1-4443-9f42-24ac004fcda12025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DEFERASIROX
DeferasiroxDEFERASIROXActavis Pharma, Inc.ad73cb1f-41d6-4cde-9abc-fc2cb7e04c952025-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
DEFERASIROXDEFERASIROXAurobindo Pharma Limitedc220484e-1e6a-4a0c-a221-60223f3bc24c2025-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DEFERASIROX
generic name: DEFERASIROX
DeferasiroxDEFERASIROXAscend Laboratories, LLCda3295fc-5210-46a3-a5cc-7b9ec9265eca2025-07-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
DeferasiroxDEFERASIROXAscend Laboratories, LLC0fb210b3-6a3d-4313-83ce-52012e384f9b2025-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
DeferasiroxDEFERASIROXBionpharma Inc.dc690f20-533e-490e-b13d-143382e023512025-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
DeferasiroxDEFERASIROXCamber Pharmaceuticals, Inc.65453013-c360-4835-8358-2a278a4a32db2025-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
Deferasirox Oral GranulesDEFERASIROXEPIC PHARMA, LLC7eda83c3-a282-47f6-9f06-d2f9612f5c5b2025-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DEFERASIROX
deferasiroxDEFERASIROXZydus Lifesciences Limitedfcd2ffe2-c8ba-400b-b7f9-e0e4b3510b982024-11-26Name fallback
brand name: deferasirox
generic name: DEFERASIROX
deferasiroxDEFERASIROXGlenmark Pharmaceuticals Inc., USA59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c2024-11-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: deferasirox
generic name: DEFERASIROX
DeferasiroxDEFERASIROXDr. Reddy's Laboratories Inc350dfc39-d03d-e221-22e9-3880728c955c2024-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
DeferasiroxDEFERASIROXXiromed, LLC4c36bb5a-2552-46c1-8500-4ae783cffef12024-09-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
DeferasiroxDEFERASIROXTeva Pharmaceuticals, Inc.e9054806-2721-4736-9aef-81ffb8db75d12024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Deferasirox
generic name: DEFERASIROX
DEFERASIROXDEFERASIROXAurobindo Pharma Limitedc7f14819-1abc-4abf-b55b-cf89beaf124e2024-05-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DEFERASIROX
generic name: DEFERASIROX
DEFERASIROXDEFERASIROXCamber Pharmaceuticals, Inc.eded6687-ba78-4117-a316-eec56d46a08a2024-05-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DEFERASIROX
generic name: DEFERASIROX
DEFERASIROXDEFERASIROXNorthStar Rx LLC57cf1650-88f9-474e-9e19-df451a15619d2023-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DEFERASIROX
generic name: DEFERASIROX
deferasiroxDEFERASIROXSun Pharmaceutical Industries, Inc.4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b2023-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: deferasirox
generic name: DEFERASIROX