PEGFILGRASTIM - Food and Drug Administration

Set ID
7979a9c8-e75a-40a9-87cc-a5f08355aaef
Type
Indexing - product concept
Effective date
2023-06-26
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use NEULASTA safely and effectively. See full prescribing information for NEULASTA. NEULASTA ® (pegfilgrastim) injection, for subcutaneous use Initial U.S. Approval: 2002Product nameAmgen, Inc | Amgen Manufacturing Limited LLC2026-08-10
These highlights do not include all the information needed to use ARMLUPEG safely and effectively. See full prescribing information for ARMLUPEG. ARMLUPEG (pegfilgrastim-unne) injection, for subcutaneous use Initial U.S. Approval: 2025 ARMLUPEG (pegfilgrastim-unne) is biosimilar* to NEULASTA (pegfilgrastim) (1)Product nameLupin Pharmaceuticals, Inc. | Lupin Limited2026-07-23
These highlights do not include all the information needed to use NYVEPRIA safely and effectively. See full prescribing information for NYVEPRIA. NYVEPRIA™ (pegfilgrastim-apgf) injection, for subcutaneous use Initial U.S. Approval: 2020 NYVEPRIA (pegfilgrastim-apgf) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differeProduct namePfizer Laboratories Div Pfizer Inc | Hospira Zagreb d.o.o. | Pfizer Inc2026-06-02
These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim).Product nameSandoz Inc2026-05-14
These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim).Product nameSandoz Inc2026-05-14
These highlights do not include all the information needed to use UDENYCA safely and effectively. See full prescribing information for UDENYCA. UDENYCA ® (pegfilgrastim-cbqv) injection, for subcutaneous use INITIAL U.S. APPROVAL: 2018 UDENYCA (pegfilgrastim-cbqv) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differenceProduct nameAccord BioPharma, Inc.2026-04-23
These highlights do not include all the information needed to use ARMLUPEG safely and effectively. See full prescribing information for ARMLUPEG. ARMLUPEG (pegfilgrastim-unne) injection, for subcutaneous use Initial U.S. Approval: 2025 ARMLUPEG (pegfilgrastim-unne) is biosimilar* to NEULASTA (pegfilgrastim) (1)Product nameLupin Pharmaceuticals, Inc. | Lupin Limited2026-04-01
These highlights do not include all the information needed to use NEULASTA safely and effectively. See full prescribing information for NEULASTA. NEULASTA ® (pegfilgrastim) injection, for subcutaneous use Initial U.S. Approval: 2002Product nameAmgen, Inc | Amgen Manufacturing Limited LLC2026-03-10
These highlights do not include all the information needed to use ARMLUPEG safely and effectively. See full prescribing information for ARMLUPEG. ARMLUPEG (pegfilgrastim-unne) injection, for subcutaneous use Initial U.S. Approval: 2025 ARMLUPEG (pegfilgrastim-unne) is biosimilar* to NEULASTA (pegfilgrastim) (1)Product nameLupin Pharmaceuticals, Inc. | Lupin Limited2026-02-23
These highlights do not include all the information needed to use FULPHILA safely and effectively. See full prescribing information for FULPHILA. FULPHILA TM (pegfilgrastim-jmdb) injection, for subcutaneous use Initial U.S. Approval: 2018 FULPHILA TM (pegfilgrastim-jmdb) is biosimilar* to NEULASTA ® (pegfilgrastim). (1)Product nameBiocon Biologics Inc. | Biocon Biologics Limited2026-01-30
These highlights do not include all the information needed to use STIMUFEND safely and effectively. See full prescribing information for STIMUFEND. STIMUFEND ® (pegfilgrastim-fpgk) injection, for subcutaneous use Initial U.S. Approval: 2022 STIMUFEND (pegfilgrastim-fpgk) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful diProduct nameNORTHSTAR RX LLC | Merck Biodevelopment, Martillac | FUJIFILM Diosynth Biotechnologies UK Ltd. | Merck Serono S.p.A (MS-Bari) | Merck Serono S.p.A (MS-Guidonia) | Istituto di Ricerche Biomediche Antoine marxer RBM S.P.A | Fresenius Kabi USA, LLC | Fresenius Kabi Austria GmbH2025-11-30
These highlights do not include all the information needed to use UDENYCA safely and effectively. See full prescribing information for UDENYCA. UDENYCA ® (pegfilgrastim-cbqv) injection, for subcutaneous use INITIAL U.S. APPROVAL: 2018 UDENYCA (pegfilgrastim-cbqv) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differenceProduct nameCoherus Oncology, Inc.2025-08-14
These highlights do not include all the information needed to use FYLNETRA safely and effectively. See full prescribing information for FYLNETRA . FYLNETRA ® (pegfilgrastim-pbbk ) injection, for subcutaneous use Initial U.S. Approval: 2022 FYLNETRA (pegfilgrastim-pbbk) is biosimilar* to NEULASTA (pegfilgrastim).Product nameAmneal Pharmaceuticals LLC | Kashiv BioSciences, LLC2025-04-25
These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim).Product nameSandoz Inc2024-02-27
These highlights do not include all the information needed to use FULPHILA safely and effectively. See full prescribing information for FULPHILA. FULPHILA ® (pegfilgrastim-jmdb) injection, for subcutaneous use Initial U.S. Approval: 2018 FULPHILA ® (pegfilgrastim-jmdb) is biosimilar* to NEULASTA ® (pegfilgrastim). (1)Product nameBiocon Biologics Inc. | Biocon Biologics Limited2023-12-05
These highlights do not include all the information needed to use STIMUFEND safely and effectively. See full prescribing information for STIMUFEND. STIMUFEND ® (pegfilgrastim-fpgk) injection, for subcutaneous use Initial U.S. Approval: 2022 STIMUFEND (pegfilgrastim-fpgk) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful diProduct nameFresenius Kabi USA, LLC | Merck Biodevelopment, Martillac | FUJIFILM Diosynth Biotechnologies UK Ltd. | Merck Serono S.p.A (MS-Bari) | Merck Serono S.p.A (MS-Guidonia) | Istituto di Ricerche Biomediche Antoine marxer RBM S.P.A | Fresenius Kabi Austria GmbH2023-10-24
These highlights do not include all the information needed to use NYVEPRIA safely and effectively. See full prescribing information for NYVEPRIA. NYVEPRIA™ (pegfilgrastim-apgf) injection, for subcutaneous use Initial U.S. Approval: 2020Product namePfizer Laboratories Div Pfizer Inc | Hospira Zagreb d.o.o. | Pfizer Inc2023-06-29
These highlights do not include all the information needed to use FULPHILA safely and effectively. See full prescribing information for FULPHILA. FULPHILA ® (pegfilgrastim-jmdb) injection, for subcutaneous use Initial U.S. Approval: 2018 FULPHILA ® (pegfilgrastim-jmdb) is biosimilar* to NEULASTA ® (pegfilgrastim). (1)Product nameMylan Institutional LLC2021-10-15