FDA.reportPublic FDA data

Application 010515

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISUPRELISOPROTERENOL HYDROCHLORIDEINJECTABLE;INJECTION0.2MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N010515-001ISUPRELISOPROTERENOL HYDROCHLORIDE0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N010515-001ISUPREL0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEEugia US LLC3e4050e8-7d94-4ed7-951d-1ff818ddadf12025-12-16Warnings, Adverse reactionsName fallback
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDENexus Pharmaceuticals LLCdfb97590-dcbf-47e7-bbfe-f01580eb6ed02025-09-16Warnings, Adverse reactionsName fallback
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
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDESagent Pharmaceuticalsd2a9b767-0274-49bf-83cd-2fcce9bedc782025-01-06Warnings, Adverse reactionsName fallback
generic name: ISOPROTERENOL HYDROCHLORIDE
isoproterenol hydrochlorideISOPROTERENOL HYDROCHLORIDEGland Pharma Limited2581854e-e654-4ac3-98e8-36c9f27748bf2024-10-07Warnings, Adverse reactionsName fallback
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDENordic Pharma, Inc.046f2941-3bc0-4755-861c-71bedb49e7062024-06-27Warnings, Adverse reactionsName fallback
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDENordic Pharma, Inc.124f44db-b6ba-4886-bfc7-8c71e60ac5b42024-06-20Warnings, Adverse reactionsName fallback
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEAvenacy, Inc.212af0f4-42c7-425d-8baf-9a2f594289a22024-05-15Warnings, Adverse reactionsName fallback
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
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEAmneal Pharmaceuticals LLCf80ce132-1570-43bf-b4a6-0ffbdea5d2182023-02-22Warnings, Adverse reactionsName fallback
generic name: ISOPROTERENOL HYDROCHLORIDE
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEMicro Labs Limited0f6a7651-e7b4-4ada-8ccd-2123d094a1132022-11-14Warnings, Adverse reactionsName fallback
generic name: ISOPROTERENOL HYDROCHLORIDE
ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDEAmphastar Pharmaceuticals, Inc.86b2455a-0489-405e-bd0b-9f79d3c5350d2022-10-01Warnings, Adverse reactionsName fallback
generic name: ISOPROTERENOL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
68682-433Isoproterenol HydrochlorideIsoproterenol hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72460SUPPL2022-10-24
72434SUPPL2022-10-21
49496APPL2017-08-22
40665SUPPL2015-11-17
40664SUPPL2015-11-05
40663SUPPL2015-11-05
10752SUPPL2013-03-26
40662SUPPL1999-05-05
11904SUPPL1999-05-04
10751SUPPL1999-05-04