FDA.reportPublic FDA data

Application 217814

Type
ANDA
Sponsor
RELIANCE LIFE SCI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DECITABINEDECITABINEINJECTABLE;INTRAVENOUS50MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217814-001DECITABINEDECITABINE50MG/VIALINJECTABLE / INTRAVENOUSAP2025-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217814-001AP

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
2026-08-18 06:07:402026-07A217814-001DECITABINE50MG/VIALINJECTABLE / INTRAVENOUSAP2025-12-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217814-001DECITABINE50MG/VIALINJECTABLE / INTRAVENOUSAP2025-12-19011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217814-001DECITABINE50MG/VIALINJECTABLE / INTRAVENOUSAP2025-12-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217814-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217814-001AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217814-001AP1a50c72e98297…

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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DecitabineDECITABINEBryant Ranch Prepackc731a9f0-46ee-41c3-8f89-179cab13bdd22026-05-06Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINEDr. Reddy's Laboratories Inc.358764ca-4c69-d516-af0c-bf8a348d26ca2026-03-25Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINEDr.Reddy's Laboratories Limited4e1f4eb4-19b2-eee8-3402-bd2ccf6227912026-03-25Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINEMeitheal Pharmaceuticals Inc.a535a235-e1d2-4520-93fe-b7dd9b0477842025-12-15Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINEBluePoint Laboratoriesde303068-589e-4e0a-90ed-e60b2c1a2b562025-09-29Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINEBluePoint Laboratories00caa305-fef4-471b-b9c3-4bcf5fe7b2442025-08-05Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINEMeitheal Pharmaceuticals Inc.a3771445-1c68-4883-a014-74f8793f31362025-07-23Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
decitabineDECITABINEHikma Pharmaceuticals USA Inc.8c5d6067-16a1-43ab-9e52-a33c600a5c442024-12-26Warnings, Adverse reactionsName fallback
brand name: decitabine
generic name: DECITABINE
DecitabineDECITABINEAccord Healthcare Inc.b46df7d7-d98e-4c7e-b1ee-e03e258781c42024-07-09Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINECamber Pharmaceuticals, Inc.5662c353-05d0-4bd8-87e4-c92ec9ca861e2024-06-26Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINEEugia US LLCa99f92cf-88f9-469b-aa69-44831e0bd4ab2023-07-29Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DECITABINEDECITABINEBluePoint Laboratories6c6ab831-6234-4803-8a01-5c51ec3b07162023-05-26Warnings, Adverse reactionsName fallback
brand name: DECITABINE
generic name: DECITABINE
DECITABINEDECITABINENivagen Pharmaceuticals, Inc.150537a8-10ac-422d-bf33-68b1a408e5662022-02-28Warnings, Adverse reactionsName fallback
brand name: DECITABINE
generic name: DECITABINE
DecitabineDECITABINEQilu Pharmaceutical Co., Ltd.5b2dce6f-c715-47dc-971e-06244ccd75482021-10-18Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
decitabineDECITABINEGland Pharma Limited39a26b24-e9d4-4974-9788-d025c51fc94f2021-09-15Warnings, Adverse reactionsName fallback
brand name: decitabine
generic name: DECITABINE
DecitabineDECITABINEAmneal Pharmaceuticals LLC40e7ef72-8df5-4adf-a269-4ae1c26eb6f92021-02-12Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINENovadoz Pharmaceuticals LLCa1b43089-bc88-4ac6-bdee-9cc38ec30f4e2021-01-01Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINENorthstar Rx LLC1abbe952-58bc-4dbc-b06a-fb79167bcd662020-08-17Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINENovadoz Pharmaceuticals LLCae6c4580-3a3a-4c42-903a-1565d79521f82020-08-01Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE
DecitabineDECITABINEMylan Institutional LLC447a9fbd-106d-4ff6-8fd0-bb38a8c90e172020-07-26Warnings, Adverse reactionsName fallback
brand name: Decitabine
generic name: DECITABINE