FDA.reportPublic FDA data

Application 080997

Type
ANDA
Sponsor
ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION20MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080997-001SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONApproved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080997-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080997-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080997-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONApproved before 1982a50c72e98297…

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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEREMEDYREPACK INC.efe5a242-5ba0-4b14-844c-206a79850d812026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
QUELICINSUCCINYLCHOLINE CHLORIDEHospira, Inc.fb08161e-7711-406d-e7b3-ea4515c079832026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDESomerset Therapeutics, LLC690a0231-dbba-4695-a843-842a14c6587c2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDESomerset Therapeutics, LLC499a4ba0-d466-4342-88da-9f1eb60986922026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDENordic Pharma, Inc.1e5891e2-e1e4-4587-b32c-b2e8082df9b62026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDESTERISCIENCE SPECIALTIES PRIVATE LIMITED1d4302db-a0d5-d0e8-e063-6294a90a22f82025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEHenry Schein, Inc.7d0f0431-e616-49c2-80d8-0752a45428db2025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SUCCINYLCHOLINE CHLORIDE
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEPiramal Critical Care Incb94ff0a2-a770-47a6-e053-2995a90a7fbc2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEMeitheal Pharmaceuticals Inc.e21bff70-5247-4763-b984-b939eb0a1fc12025-09-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEProPharma Distribution386a63e7-d062-a4c7-e063-6394a90ae77c2025-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEFresenius Kabi USA LLCf4d496fb-588f-459d-b218-0fc0ffa2715f2025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEFresenius Kabi USA LLCce12d907-eae4-4fba-b85e-170fac1819c62025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEDevatis, Inc.e235eb7d-5ce2-4884-9d16-493c90d7beba2024-11-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDECamber Pharmaceuticals, Inc.3deac02b-392c-4ee4-9abf-7fe5b89751472024-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEBaxter Healthcare Corporation30f58922-3c74-4813-ace0-fcd2024acd092024-06-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SUCCINYLCHOLINE CHLORIDE
generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEFresenius Kabi USA, LLC4e2d3394-c9e0-4191-ba0d-da21034c22b52024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SUCCINYLCHOLINE CHLORIDE
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEBE Pharmaceuticals Inc.6e6e0ce7-c73c-407f-9678-724425f249762023-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Succinylcholine Chloride
generic name: SUCCINYLCHOLINE CHLORIDE
AnectineSUCCINYLCHOLINE CHLORIDESandoz Inca1e5d29f-111e-4a44-addf-beeb6ea817112023-11-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
AnectineSUCCINYLCHOLINE CHLORIDECivica, Inc.0b990f84-9515-44bd-a97d-a97bbead065c2023-11-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
AnectineSUCCINYLCHOLINE CHLORIDESandoz Inc04a4e6f5-6fa1-42e1-a3f9-21fca7786b152023-11-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE

Reported adverse events (FAERS/openFDA)#

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