FDA.reportPublic FDA data

Application 218536

Type
ANDA
Sponsor
STIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SELENIOUS ACIDSELENIOUS ACIDSOLUTION;INTRAVENOUSEQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)NoNo
002SELENIOUS ACIDSELENIOUS ACIDSOLUTION;INTRAVENOUSEQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218536-001SELENIOUS ACIDSELENIOUS ACIDEQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)SOLUTION / INTRAVENOUSAP2025-12-31
A218536-002SELENIOUS ACIDSELENIOUS ACIDEQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)SOLUTION / INTRAVENOUSAP2025-12-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A218536-001AP
A218536-002AP

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
2026-02-19 14:30 UTC2026-02A218536-001SELENIOUS ACIDEQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)SOLUTION / INTRAVENOUSAP2025-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218536-002SELENIOUS ACIDEQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)SOLUTION / INTRAVENOUSAP2025-12-31011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218536-001SELENIOUS ACIDEQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)SOLUTION / INTRAVENOUSAP2025-12-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218536-002SELENIOUS ACIDEQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)SOLUTION / INTRAVENOUSAP2025-12-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218536-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218536-002AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218536-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218536-002AP1a50c72e98297…

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 · 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