FDA.reportPublic FDA data

Application 071388

Type
ANDA
Sponsor
ROXANE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPRANOLOL HYDROCHLORIDE INTENSOLPROPRANOLOL HYDROCHLORIDECONCENTRATE;ORAL80MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A071388-001PROPRANOLOL HYDROCHLORIDE INTENSOLPROPRANOLOL HYDROCHLORIDE80MG/MLCONCENTRATE / ORAL1987-05-15

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A071388-001PROPRANOLOL HYDROCHLORIDE INTENSOL80MG/MLCONCENTRATE / ORAL1987-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071388-001PROPRANOLOL HYDROCHLORIDE INTENSOL80MG/MLCONCENTRATE / ORAL1987-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071388-001PROPRANOLOL HYDROCHLORIDE INTENSOL80MG/MLCONCENTRATE / ORAL1987-05-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A071388-001PROPRANOLOL HYDROCHLORIDE INTENSOL80MG/MLCONCENTRATE / ORAL1987-05-15a50c72e98297…

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 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEGolden State Medical Supply, Inc.5affa0ea-db84-86fd-e063-6294a90a4d162026-09-08Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.f7ae2dac-6048-41ea-95d3-cad06cc2baf32026-09-03Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingc751ee54-27b4-4ed7-829a-ced735c413122026-09-02Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packagingd027f39e-7648-44c8-a8dc-b26b4cdd81be2026-09-02Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Inderal XLPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.ac196ff5-9215-402b-bc57-69aa87f8bade2026-08-27Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
InnoPran XLPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.cd5601b3-4d87-4c3b-acac-b476e787609d2026-08-27Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride ERPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.5415904b-90da-48e8-9f9e-f86749aa129c2026-08-27Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPar Health USA, LLC0d74bb04-8227-4afa-b523-ce1556150e072026-08-26Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.52da1afc-7f1c-4893-ab84-8479dd9399512026-08-24Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.1791ef4d-b609-41c8-b4ef-15bff752ddd72026-08-24Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.d9759182-e681-4c7e-af36-9f7b2184df3c2026-08-24Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
INDERAL LAPROPRANOLOL HYDROCHLORIDEANI Pharmaceuticals, Inc.35d28979-36b1-4630-b85e-a44e0a4437342026-08-24Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECreekwood Pharmaceuticals LLC289f39f4-ebd3-4fd9-bbb3-72de8124795a2026-08-21Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.a3bd3ef9-539d-450e-900b-95be0e46095b2026-08-10Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmafa5b6189-3419-4134-8bfe-c0d0c77df8282026-08-10Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.e3f615e0-07da-491c-9620-7083f4f4318a2026-08-07Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.1cd914b6-b250-4b11-8404-41db3589361e2026-08-05Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.07c3fcab-33fe-4a6a-ba67-2d042190c1462026-08-04Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.49d09308-74b0-4f9a-9c03-37234b5ee3a32026-07-29Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC1df7f35e-b1d8-4aca-875e-d197cb61239e2026-07-29Warnings, Adverse reactionsName fallback
generic name: PROPRANOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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