SPESOLIMAB - Food and Drug Administration

Set ID: e1c7d730-1f8a-459d-b248-0fb8a3a883af
Type: Indexing - product concept
Effective date: 2023-06-26
Version: 1
Source: DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
Label	Relation	Manufacturer	Effective
These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Product name	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.	2026-04-08
These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Product name	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.	2026-03-16
These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Product name	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.	2025-10-27
These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Product name	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.	2025-06-02

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
0597-0035	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
0597-0035-10	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
0597-0620	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
0597-0620-10	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
0597-0620-20	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
0597-7705	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
0597-7705-38	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
0597-7705-41	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
0597-7705-72	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
50222-360	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
50222-360-72	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
50222-361	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
50222-361-02	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
50222-361-11	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
50222-362	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
50222-362-01	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
50222-362-02	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.
50222-362-12	These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.