FDA.reportPublic FDA data

Application 083486

Type
ANDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDEINJECTABLE;INJECTION0.2MG/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
A083486-001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE0.2MG/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 UTC2022-09A083486-001ISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A083486-001ISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A083486-001ISOPROTERENOL HYDROCHLORIDE0.2MG/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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isoproterenol hydrochlorideISOPROTERENOL HYDROCHLORIDEKVK-Tech, Inc.051acbc2-7bf8-4059-e063-6394a90a115b2026-03-17Warnings, Adverse reactionsName fallback
brand name: Isoproterenol hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEEugia US LLC3e4050e8-7d94-4ed7-951d-1ff818ddadf12025-12-16Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDENexus Pharmaceuticals LLCdfb97590-dcbf-47e7-bbfe-f01580eb6ed02025-09-16Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d140b27a-3bf7-4e0f-bb91-02b588184f522025-06-23Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDESagent Pharmaceuticalsd2a9b767-0274-49bf-83cd-2fcce9bedc782025-01-06Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
isoproterenol hydrochlorideISOPROTERENOL HYDROCHLORIDEGland Pharma Limited2581854e-e654-4ac3-98e8-36c9f27748bf2024-10-07Warnings, Adverse reactionsName fallback
brand name: isoproterenol hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDENordic Pharma, Inc.046f2941-3bc0-4755-861c-71bedb49e7062024-06-27Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDENordic Pharma, Inc.124f44db-b6ba-4886-bfc7-8c71e60ac5b42024-06-20Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEAvenacy, Inc.212af0f4-42c7-425d-8baf-9a2f594289a22024-05-15Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
ISOPROTERENOLISOPROTERENOL HYDROCHLORIDECipla USA Inc.f724120d-da28-4065-9e05-d7dd6afbb5462024-01-14Warnings, Adverse reactionsName fallback
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEArmas Pharmaceuticals Inc.56cb205c-8329-454a-a6be-e05e497de81e2023-07-27Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEAmneal Pharmaceuticals LLCf80ce132-1570-43bf-b4a6-0ffbdea5d2182023-02-22Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEMicro Labs Limited0f6a7651-e7b4-4ada-8ccd-2123d094a1132022-11-14Warnings, Adverse reactionsName fallback
brand name: Isoproterenol Hydrochloride
generic name: ISOPROTERENOL HYDROCHLORIDE
ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDEAmphastar Pharmaceuticals, Inc.86b2455a-0489-405e-bd0b-9f79d3c5350d2022-10-01Warnings, Adverse reactionsName fallback
brand name: ISOPROTERENOL HYDROCHLORIDE
generic name: ISOPROTERENOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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