FDA.reportPublic FDA data

Application 075559

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTORPHANOL TARTRATEBUTORPHANOL TARTRATEINJECTABLE;INJECTION1MG/MLNoNo
002BUTORPHANOL TARTRATEBUTORPHANOL TARTRATEINJECTABLE;INJECTION2MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A075559-001BUTORPHANOL TARTRATEBUTORPHANOL TARTRATE1MG/MLINJECTABLE / INJECTION2000-03-20
A075559-002BUTORPHANOL TARTRATEBUTORPHANOL TARTRATE2MG/MLINJECTABLE / INJECTION2000-03-20

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.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A075559-001BUTORPHANOL TARTRATE1MG/MLINJECTABLE / INJECTION2000-03-20f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A075559-002BUTORPHANOL TARTRATE2MG/MLINJECTABLE / INJECTION2000-03-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075559-001BUTORPHANOL TARTRATE1MG/MLINJECTABLE / INJECTION2000-03-20e64feba35796…
2022-09-29 23:25 UTC2022-09A075559-002BUTORPHANOL TARTRATE2MG/MLINJECTABLE / INJECTION2000-03-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075559-001BUTORPHANOL TARTRATE1MG/MLINJECTABLE / INJECTION2000-03-20cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075559-002BUTORPHANOL TARTRATE2MG/MLINJECTABLE / INJECTION2000-03-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075559-001BUTORPHANOL TARTRATE1MG/MLINJECTABLE / INJECTION2000-03-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075559-002BUTORPHANOL TARTRATE2MG/MLINJECTABLE / INJECTION2000-03-20a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butorphanol TartrateBUTORPHANOL TARTRATEApotex Corp.b8e48063-0b40-ee43-85c1-4ef2de80c4042026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butorphanol Tartrate
generic name: BUTORPHANOL TARTRATE
Butorphanol TartrateBUTORPHANOL TARTRATEBryant Ranch Prepack412499ce-db93-4943-ae1a-564c27b1fb162026-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butorphanol Tartrate
generic name: BUTORPHANOL TARTRATE
Butorphanol TartrateBUTORPHANOL TARTRATEHikma Pharmaceuticals USA Inc.5a50d22e-acbe-4b15-9ed6-70713378408a2025-11-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butorphanol Tartrate
generic name: BUTORPHANOL TARTRATE
Butorphanol TartrateBUTORPHANOL TARTRATEHikma Pharmaceuticals USA Inc.bded5531-8847-4576-9a29-3e44f979d2e02024-04-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Butorphanol Tartrate
generic name: BUTORPHANOL TARTRATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8716ORIG2000-03-20