BRIGATINIB - Food and Drug Administration

Set ID: 7e54a2c5-e3f2-4273-8a10-321aacfdbb07
Type: Indexing - product concept
Effective date: 2020-10-30
Version: 2
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 ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Product name	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited	2026-01-12

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
63020-090	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited
63020-090-07	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited
63020-090-30	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited
63020-113	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited
63020-113-30	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited
63020-180	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited
63020-180-23	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited
63020-180-30	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited
63020-198	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited
63020-198-30	These highlights do not include all the information needed to use ALUNBRIG safely and effectively. See full prescribing information for ALUNBRIG. ALUNBRIG ® (brigatinib) tablets, for oral use Initial U.S. Approval: 2017	Takeda Pharmaceuticals America, Inc. \| AMPAC Fine Chemicals LLC \| Curia New York, Inc. \| Ajinomoto Omnichem \| Solvias AG \| Penn Pharmaceutical Services Limited \| Almac Sciences (Ireland) Limited \| Takeda Ireland Limited