FDA.reportPublic FDA data

Application 070752

Type
ANDA
Sponsor
ABRAXIS PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALBUPHINENALBUPHINE HYDROCHLORIDEINJECTABLE;INJECTION20MG/MLNoNo
002NALBUPHINENALBUPHINE HYDROCHLORIDESOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS200MG/10ML (20MG/ML)NoNo

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
A070752-001NALBUPHINENALBUPHINE HYDROCHLORIDE20MG/ML (20MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS1986-09-24
A070752-002NALBUPHINENALBUPHINE HYDROCHLORIDE200MG/10ML (20MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS1986-09-24

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 2 of 2 · 51 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070752-001NALBUPHINE20MG/MLINJECTABLE / INJECTION1986-09-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070752-001NALBUPHINE20MG/MLINJECTABLE / INJECTION1986-09-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070752-001NALBUPHINE20MG/MLINJECTABLE / INJECTION1986-09-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A070752-001NALBUPHINE20MG/MLINJECTABLE / INJECTION1986-09-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A070752-001NALBUPHINE20MG/MLINJECTABLE / INJECTION1986-09-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070752-001NALBUPHINE20MG/MLINJECTABLE / INJECTION1986-09-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070752-001NALBUPHINE20MG/MLINJECTABLE / INJECTION1986-09-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070752-001NALBUPHINE20MG/MLINJECTABLE / INJECTION1986-09-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070752-001NALBUPHINE20MG/MLINJECTABLE / INJECTION1986-09-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A070752-001NALBUPHINE20MG/ML (20MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS1986-09-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A070752-002NALBUPHINE200MG/10ML (20MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS1986-09-24a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.a99fe500-f52b-483c-807c-178f1a78a02b2026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHenry Schein, Inc.dd621bfa-ce48-4c27-b247-a6d885f70b722026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHenry Schein, Inc.4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d2026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHospira, Inc.6025e8d4-5083-4c3a-58a0-050e7b0b61502025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEProPharma Distribution38569b5f-fb37-135e-e063-6294a90a54df2025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEHenry Schein, Inc.596826ff-e471-4d4f-9a73-2a34e2af2dd62025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine hydrochlorideNALBUPHINE HYDROCHLORIDESomerset Therapeutics, LLCa3221c05-5822-4ab8-b589-0e3939b91a682025-03-26Boxed warning, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine hydrochlorideNALBUPHINE HYDROCHLORIDEMedical Purchasing Solutions, LLC292b0d0e-f222-d384-e063-6394a90acd442024-12-13Boxed warning, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEMedical Purchasing Solutions, LLC28f274a4-62c4-4e54-e063-6394a90a22002024-12-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine hydrochlorideNALBUPHINE HYDROCHLORIDESomerset Therapeutics, LLCd82dafac-cce7-445a-8127-2a10b6d947ca2024-09-26Boxed warning, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine HydrochlorideNALBUPHINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6bde2184-5643-3ec6-e053-2991aa0a115f2023-05-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NALBUPHINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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