FDA.reportPublic FDA data

Application 220051

Type
ANDA
Sponsor
BPI LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SELENIOUS ACIDSELENIOUS ACIDINJECTION12UG/2MLNoNo
003SELENIOUS ACIDSELENIOUS ACIDINJECTION60UG/1MLNoNo

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 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Selenious AcidSELENIOUS ACIDPangea Pharmaceuticals, LLC4adcba5d-74c7-4353-b54d-539ef89754d62026-01-07Warnings, Adverse reactionsName fallback
brand name: Selenious Acid
generic name: SELENIOUS ACID
Selenious AcidSELENIOUS ACIDGland Pharma Limited1be55144-afc8-45ff-82a9-162a6279d2a82025-07-09Warnings, Adverse reactionsName fallback
brand name: Selenious Acid
generic name: SELENIOUS ACID
Selenious AcidSELENIOUS ACIDAmerican Regent, Inc.49324999-50e3-43ed-a8dd-156d6dbedd9f2021-08-01Warnings, Adverse reactionsName fallback
brand name: Selenious Acid
generic name: SELENIOUS ACID

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84993ORIG 2026-02-11
84992ORIG 2026-02-11