FDA.reportPublic FDA data

Application 215820

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHYTONADIONEPHYTONADIONEINJECTABLE;INJECTION1MG/0.5MLNoNo

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
A215820-001PHYTONADIONEPHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB12026-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215820-001AB1

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215820-001PHYTONADIONE1MG/0.5MLINJECTABLE / INJECTIONAB12026-05-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215820-001AB11a50c72e98297…

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