FDA.reportPublic FDA data

Application 203170

Type
ANDA
Sponsor
JIANGSU HENGRUI MED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCETAXELDOCETAXELINJECTABLE;INJECTION40MG/MLNoYes

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

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
A203170-001DOCETAXELDOCETAXEL40MG/MLINJECTABLE / INJECTION2017-02-15

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A203170-001DOCETAXEL40MG/MLINJECTABLE / INJECTION2017-02-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203170-001DOCETAXEL40MG/MLINJECTABLE / INJECTION2017-02-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203170-001DOCETAXEL40MG/MLINJECTABLE / INJECTION2017-02-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203170-001DOCETAXEL40MG/MLINJECTABLE / INJECTION2017-02-15a50c72e98297…

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 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DocetaxelDOCETAXEL ANHYDROUSMylan Institutional LLC2992d633-08fa-44f3-b14d-41700f24686b2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
DocetaxelDOCETAXELHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.81686d37-a13f-46e2-b439-a84eb14336342026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
BEIZRAYDOCETAXELZydus Pharmaceuticals USA Inc.8fb7d980-d6c7-468b-a9f0-adff16101a4b2025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOCETAXEL
BEIZRAYDOCETAXELZhuhai Beihai Biotech Co., Ltd.3538b979-8cac-49ed-b8dc-50f73ce38c722025-12-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOCETAXEL
DocetaxelDOCETAXEL ANHYDROUSSagent Pharmaceuticals30077f79-341f-4618-9ec5-23b17b212fae2025-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
DocetaxelDOCETAXELBaxter Healthcare Corporation654319ae-e5f9-4a6a-b566-201923153b6e2025-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
DOCIVYXDOCETAXELAvyxa Pharma, LLC4763744e-360e-4d37-be05-cce4114548cd2025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOCETAXEL
DocetaxelDOCETAXELMeitheal Pharmaceuticals Inc.f970e352-3d43-4cc4-a859-503ec37b6e222025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
DocetaxelDOCETAXELHospira, Inc.6b9999bb-869e-4d25-838c-23c3ab2800442025-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.644c5035-20d2-4686-beaa-bef08e99051c2025-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.00c61d11-d6b7-4618-b6f6-2592dbcc8af72025-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
DocetaxelDOCETAXELSanofi-Aventis U.S. LLCdd0ca36d-1f54-4568-8d19-a7152addcd522024-12-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
DocetaxelDOCETAXELHospira, Inc.3104aab1-cd6e-4ad2-8e0a-286a0c5d19402024-09-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.a0ec4bcc-93ea-4c41-a4b6-95ec194918072024-08-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
DOCETAXELDOCETAXELAccord Healthcare Inc.f59f7811-70b7-4c44-99f7-4f4fdce3ed222024-08-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DOCETAXEL
generic name: DOCETAXEL
DocetaxelDOCETAXELActavis Pharma, Inc.2c806400-5fdc-4398-8475-37f700b3191f2024-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
DocetaxelDOCETAXELEugia US LLC1263799c-13dc-488b-b158-b834736a4e662024-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
DocetaxelDOCETAXELHikma Pharmaceuticals USA Inc.ff7fb2c2-97a7-4716-a269-925ca30cf0f12024-01-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
DocetaxelDOCETAXELBaxter Healthcare Corporation0e0f06bd-d190-45da-be8b-062e8de019702023-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL
DocetaxelDOCETAXELSandoz Inc.e03d1378-6889-43d5-a34c-f96132cffa882023-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Docetaxel
generic name: DOCETAXEL

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57884-3021DocetaxelDocetaxelJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
57884-3021DocetaxelDocetaxelJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
57884-3021DocetaxelDocetaxelJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
57884-3021DocetaxelDocetaxelJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
57884-3021DocetaxelDocetaxelJiangsu Hengrui Pharmaceuticals Co., Ltd.ANDACurrent
57884-3021DocetaxelDocetaxelJiangsu Hengrui Pharmaceuticals Co., Ltd.ANDACurrent
57884-3021DocetaxelDocetaxelJiangsu Hengrui Pharmaceuticals Co., Ltd.ANDACurrent