FDA.reportPublic FDA data

Application 212322

Type
ANDA
Sponsor
AIZANT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMPAGLIFLOZINEMPAGLIFLOZINTABLET;ORAL2.5MGNoNo
002EMPAGLIFLOZINEMPAGLIFLOZINTABLET;ORAL10MGNoNo
003EMPAGLIFLOZINEMPAGLIFLOZINTABLET;ORAL25MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 1 ยท 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JardianceEMPAGLIFLOZINAphena Pharma Solutions - Tennessee, LLC334f1b3d-5670-6685-e063-6294a90a7e472026-06-17Warnings, Adverse reactionsName fallback
generic name: EMPAGLIFLOZIN
JardianceEMPAGLIFLOZINCardinal Health 107, LLC5777b8a8-ada6-4950-8548-43a1de11f0752026-02-17Warnings, Adverse reactionsName fallback
generic name: EMPAGLIFLOZIN
JardianceEMPAGLIFLOZINBoehringer Ingelheim Pharmaceuticals, Inc.faf3dd6a-9cd0-39c2-0d2e-232cb3f675652026-01-30Warnings, Adverse reactionsName fallback
generic name: EMPAGLIFLOZIN
JardianceEMPAGLIFLOZINAphena Pharma Solutions - Tennessee, LLC8b6261f6-4bdc-462e-8af1-4064664c62f32025-10-27Warnings, Adverse reactionsName fallback
generic name: EMPAGLIFLOZIN
JardianceEMPAGLIFLOZINA-S Medication Solutionsa77214ca-572e-485e-aae9-f7950187e5fb2023-08-08Warnings, Adverse reactionsName fallback
generic name: EMPAGLIFLOZIN
JARDIANCEEMPAGLIFLOZINA-S Medication Solutions942a82a4-cbbd-4e44-9965-8d03f767912b2023-07-24Warnings, Adverse reactionsName fallback
generic name: EMPAGLIFLOZIN
JARDIANCEEMPAGLIFLOZINA-S Medication Solutions1782b947-4a72-4feb-a488-1469d9af82bd2023-05-03Warnings, Adverse reactionsName fallback
generic name: EMPAGLIFLOZIN
JARDIANCEEMPAGLIFLOZINA-S Medication Solutionsf2b41c77-0abb-40ee-8578-86a748d0e19e2023-05-03Warnings, Adverse reactionsName fallback
generic name: EMPAGLIFLOZIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65882ORIG2021-01-12