FDA.reportPublic FDA data

Application 200196

Type
ANDA
Sponsor
EMCURE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATAZANAVIR SULFATEATAZANAVIR SULFATECAPSULE; ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 1 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atazanavir SulfateATAZANAVIRAurobindo Pharma Limited7fbea274-d6b5-4faa-bbf0-05fefab421142025-08-06Warnings, Adverse reactionsName fallback
brand name: Atazanavir Sulfate
Atazanavir SulfateATAZANAVIR SULFATETeva Pharmaceuticals USA, Inc.654b7e08-33d8-47e7-b37f-3681e79c7b8b2024-12-30Warnings, Adverse reactionsName fallback
brand name: Atazanavir Sulfate
generic name: ATAZANAVIR SULFATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9808ORIG2010-08-24