FDA.reportPublic FDA data

Application 087956

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VITAMIN K1PHYTONADIONEINJECTABLE;INJECTION10MG/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
A087956-001VITAMIN K1PHYTONADIONE10MG/MLINJECTABLE / INJECTION1983-07-25

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 22:54:322026-06A087956-001VITAMIN K110MG/MLINJECTABLE / INJECTION1983-07-25a50c72e98297…

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 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHYTONADIONEPHYTONADIONEHF Acquisition Co LLC, DBA HealthFirst5686f34b-446a-00ae-e063-6394a90a60292026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
Vitamin K1PHYTONADIONEHospira, Inc.e8808230-2c44-44c6-8cab-8f29b6b340512026-05-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Vitamin K1
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONESun Pharmaceutical Industries, Inc.51c175dd-02f9-68d1-e063-6294a90a4b362026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONEAmneal Pharmaceuticals Private Limitedddd351d3-8b9e-482d-9ab8-f367ce1c3cc02026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONEOrbicular Pharmaceutical Technologies Private Limitedd954e3d7-a4d5-4798-887d-7af916ff01812026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEMajor Pharmaceuticals54f23bc8-d8f3-40e8-a93d-3121cc581d542026-03-16Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONESagent Pharmaceuticals3d571642-3d3a-41ae-855e-304ae4fff4592026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEGLENMARK PHARMACEUTICALS INC60e5abd1-e2fa-4a5e-b25b-3ec6cfdeed142025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEAgnitio Inc.66ada4f8-c5a9-49f1-848f-e172416892a12025-12-01Adverse reactionsName fallback
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONEHenry Schein, Inc.1cf90be3-a744-4db5-999d-a84c673723042025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONEHenry Schein, Inc.0d971993-466c-46dd-bdd6-2e300173621e2025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
phytonadionePHYTONADIONEAmneal Pharmaceuticals LLC2ce1dd90-11ad-4f74-af16-45b7e59f05da2025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEAlembic Pharmaceuticals Limited6ccb76ab-1549-4a47-a119-8059588ad83d2025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEAlembic Pharmaceuticals Inc.b1e53422-c85d-4bb6-af4f-24934cc319b02025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONECoupler LLC3e4f86c4-7e89-c864-e063-6394a90a59af2025-09-08Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEXiromed LLCa4b394e7-b766-824e-a8bf-f56808de76e12025-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONECaplin Steriles Limited114b1330-6f03-476c-8678-8cd0da189bce2025-04-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEFresenius Kabi USA, LLC02a39690-38e6-42e9-9897-391c2df9e07e2025-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONECipla USA Inc.4bc2de7b-6564-4d77-8a65-6be57b7060932025-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEGland Pharma Limitedc375bfab-5a4b-40f3-a783-8372158af8602024-12-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE