FDA.reportPublic FDA data

Application 076233

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PACLITAXELPACLITAXELINJECTABLE;INJECTION6MG/MLNoNo

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

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
A076233-001PACLITAXELPACLITAXEL6MG/MLINJECTABLE / INJECTION2002-08-01

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
2026-08-01 22:54:322026-06A076233-001PACLITAXEL6MG/MLINJECTABLE / INJECTION2002-08-01a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PaclitaxelPACLITAXELTeva Parenteral Medicines, Inc.fbd32bd2-9685-41cb-bee2-730a45526b652026-07-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PaclitaxelPACLITAXELTeva Parenteral Medicines, Inc.e4be6cbf-72b9-4f7f-9b1b-459b2d35961a2026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PaclitaxelPACLITAXELHospira, Inc.ea28753a-8631-460a-bfdc-b101eb8ac84a2026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PaclitaxelPACLITAXELBluePoint Laboratories59906bd2-8337-4cd8-9288-65b90eac2a7a2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PACLITAXELPACLITAXELMylan Institutional LLCa1a06de1-d9a4-460a-b87d-5e40305b065c2026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PACLITAXEL
generic name: PACLITAXEL
PaclitaxelPACLITAXELBryant Ranch Prepack30384708-1fcd-4a75-94d7-9d5d617a37b62026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PaclitaxelPACLITAXEL (AIBUMIN-BOUND)Ningbo Shuangcheng Pharmaceutical Co., Ltd4df3fda6-0b29-420e-ab91-81441ce914ed2026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
PaclitaxelPACLITAXELNatco Pharma USA LLCa1eb16b4-285b-4e81-9c4e-1244d4a52af82026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PACLITAXEL PACLITAXELPACLITAXELHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b4c5d08a-e0f5-4af1-97d6-213705adedf12025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PACLITAXEL
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)PACLITAXELNorthStar Rx LLC1e9d5093-fbfc-470a-8520-811c46a8870c2025-09-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PACLITAXEL
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)PACLITAXELBluePoint Laboratories36d4a2ed-4b34-4b06-e063-6394a90acc862025-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PACLITAXEL
PaclitaxelPACLITAXELBluePoint Laboratories9e7bc2c2-a369-4c6f-9dd9-ee98ddaae8332025-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PaclitaxelPACLITAXELSandoz Inc15ca4829-8fee-45f9-b4bc-b31c15732cd62025-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)PACLITAXELMeitheal Pharmaceuticals Inc.31e893aa-8d9e-4576-8614-eb2fe772bde42025-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PACLITAXEL
PaclitaxelPACLITAXELFresenius Kabi USA, LLCa6c24189-293f-42ca-b969-75870bb55af02024-09-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PaclitaxelPACLITAXELAlembic Pharmaceuticals Inc.0c12c77c-5fd4-48dc-a318-e968922339922024-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PaclitaxelPACLITAXELSagent Pharmaceuticals5721b9bf-c3c1-4b73-b96c-5fbe3147b6a52024-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PaclitaxelPACLITAXELTeva Pharmaceuticals, Inc.15dd51ed-29e8-468b-b6d1-21b1f84d6f2e2023-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL
PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUNDPACLITAXELAmerican Regent, Inc.f06d1bb3-83f1-4d84-8004-4c6681ad8a5a2023-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PACLITAXEL
PaclitaxelPACLITAXELAlembic Pharmaceuticals Limited6d04b514-c85c-4db1-919e-21dd981727912023-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paclitaxel
generic name: PACLITAXEL

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43065ORIG2005-07-22