FDA.reportPublic FDA data

Application 212112

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHYTONADIONEPHYTONADIONETABLET;ORAL5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212112-001PHYTONADIONEPHYTONADIONE5MGTABLET / ORAL2024-12-19

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
2026-09-14 22:38:342026-08A212112-001PHYTONADIONE5MGTABLET / ORAL2024-12-1984e616aacf4f…
2026-08-18 06:07:402026-07A212112-001PHYTONADIONE5MGTABLET / ORAL2024-12-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212112-001PHYTONADIONE5MGTABLET / ORAL2024-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212112-001PHYTONADIONE5MGTABLET / ORAL2024-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A212112-001PHYTONADIONE5MGTABLET / ORAL2024-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212112-001PHYTONADIONE5MGTABLET / ORAL2024-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212112-001PHYTONADIONE5MGTABLET / ORALAB2024-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212112-001PHYTONADIONE5MGTABLET / ORALAB2024-12-1903ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212112-001PHYTONADIONE5MGTABLET / ORAL2024-12-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212112-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212112-001AB103ed91905a0d…

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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhytonadionePHYTONADIONEAmneal Pharmaceuticals NY LLC54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d2024-12-09Adverse reactionsName fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEAmerican Health Packaging88d13044-6ce8-4374-86ff-e8d9eea278292024-09-24Adverse reactionsName fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PhytonadionePHYTONADIONENorthstar Rx LLC.5429b58b-ec2b-4a18-95d9-a9d8043211922024-08-05Adverse reactionsName fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEZydus Pharmaceuticals USA Inc.6c992275-b040-42d0-9eff-570dce4272fe2024-08-05Adverse reactionsName fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PhytonadionePHYTONADIONECipla USA Inc.1add4de5-0f9c-453e-9dd5-abb8077b566a2024-07-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEInternational Medication Systems, Limitede0b0c8f1-75be-4f25-898a-7b97b608c6152024-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PHYTONADIONEPHYTONADIONEBaxter Healthcare Corporation98fa1675-8af1-42c5-bbab-8b3632d52a0f2023-12-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PHYTONADIONE
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEExelan Pharmaceuticals, Inc.63771c95-d4f5-42eb-b591-4df146f18cb02023-11-01Adverse reactionsName fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PhytonadionePHYTONADIONECipla USA., Inc.7dd1f275-94d3-45d2-a4d0-696ce60a2a9b2023-11-01Adverse reactionsName fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEScieGen Pharmaceuticals Incc0e38a20-7225-46a5-9730-924cbd08dbee2023-08-11Adverse reactionsName fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PhytonadionePHYTONADIONEZydus Lifesciences Limitedfa26f747-c64e-4090-a0cf-de3d3d9b004c2022-11-01Name fallback
brand name: Phytonadione
generic name: PHYTONADIONE
PHYTONADIONE PHYTONADIONEPHYTONADIONEDr.Reddy's Laboratories Inc02445c07-7b4b-cd70-54e8-ebefc814f5472019-05-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PHYTONADIONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.