AMIFAMPRIDINE - Food and Drug Administration

Set ID: be5e1632-ea67-4526-852b-e88fa4d9ee01
Type: Indexing - product concept
Effective date: 2019-08-02
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 FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018	Product name	Catalyst Pharmaceuticals, Inc. \| Catalent Micron Technologies, Inc. \| Pharmaceutics International, Inc. \| PCI Pharma Services Canada, Inc. \| Quality Chemical Laboratories, LLC \| Robertson-Microlit Laboratories Inc. \| SGS Canada Inc. \| SGS North America Inc.	2026-04-16

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
69616-211	These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018	Catalyst Pharmaceuticals, Inc. \| Catalent Micron Technologies, Inc. \| Pharmaceutics International, Inc. \| PCI Pharma Services Canada, Inc. \| Quality Chemical Laboratories, LLC \| Robertson-Microlit Laboratories Inc. \| SGS Canada Inc. \| SGS North America Inc.
69616-211-03	These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018	Catalyst Pharmaceuticals, Inc. \| Catalent Micron Technologies, Inc. \| Pharmaceutics International, Inc. \| PCI Pharma Services Canada, Inc. \| Quality Chemical Laboratories, LLC \| Robertson-Microlit Laboratories Inc. \| SGS Canada Inc. \| SGS North America Inc.
69616-211-04	These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018	Catalyst Pharmaceuticals, Inc. \| Catalent Micron Technologies, Inc. \| Pharmaceutics International, Inc. \| PCI Pharma Services Canada, Inc. \| Quality Chemical Laboratories, LLC \| Robertson-Microlit Laboratories Inc. \| SGS Canada Inc. \| SGS North America Inc.
69616-211-06	These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018	Catalyst Pharmaceuticals, Inc. \| Catalent Micron Technologies, Inc. \| Pharmaceutics International, Inc. \| PCI Pharma Services Canada, Inc. \| Quality Chemical Laboratories, LLC \| Robertson-Microlit Laboratories Inc. \| SGS Canada Inc. \| SGS North America Inc.
69616-211-08	These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018	Catalyst Pharmaceuticals, Inc. \| Catalent Micron Technologies, Inc. \| Pharmaceutics International, Inc. \| PCI Pharma Services Canada, Inc. \| Quality Chemical Laboratories, LLC \| Robertson-Microlit Laboratories Inc. \| SGS Canada Inc. \| SGS North America Inc.