Application 008847

Type
NDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUCOSTRINSUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION20MG/MLNoNo
003SUCOSTRINSUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION100MG/MLNoNo

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

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
N008847-001SUCOSTRINSUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982
N008847-003SUCOSTRINSUCCINYLCHOLINE CHLORIDE100MG/MLINJECTABLE / INJECTIONRLD, Approved 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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N008847-001SUCOSTRIN20MG/MLINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N008847-003SUCOSTRIN100MG/MLINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…

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
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
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDESomerset Therapeutics, LLC499a4ba0-d466-4342-88da-9f1eb60986922026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDENordic Pharma, Inc.1e5891e2-e1e4-4587-b32c-b2e8082df9b62026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDESTERISCIENCE SPECIALTIES PRIVATE LIMITED1d4302db-a0d5-d0e8-e063-6294a90a22f82025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEHenry Schein, Inc.7d0f0431-e616-49c2-80d8-0752a45428db2025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEPiramal Critical Care Incb94ff0a2-a770-47a6-e053-2995a90a7fbc2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEMeitheal Pharmaceuticals Inc.e21bff70-5247-4763-b984-b939eb0a1fc12025-09-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEProPharma Distribution386a63e7-d062-a4c7-e063-6394a90ae77c2025-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEFresenius Kabi USA LLCf4d496fb-588f-459d-b218-0fc0ffa2715f2025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEFresenius Kabi USA LLCce12d907-eae4-4fba-b85e-170fac1819c62025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEDevatis, Inc.e235eb7d-5ce2-4884-9d16-493c90d7beba2024-11-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDECamber Pharmaceuticals, Inc.3deac02b-392c-4ee4-9abf-7fe5b89751472024-10-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEBaxter Healthcare Corporation30f58922-3c74-4813-ace0-fcd2024acd092024-06-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEFresenius Kabi USA, LLC4e2d3394-c9e0-4191-ba0d-da21034c22b52024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEBE Pharmaceuticals Inc.6e6e0ce7-c73c-407f-9678-724425f249762023-12-19Boxed warning, Warnings, Adverse reactionsName fallback
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.