LEUPROLIDE ACETATE - Food and Drug Administration

Set ID
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5
Type
Indexing - product concept
Effective date
2023-08-29
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
Leuprolide Acetate Injection [14 mg/2.8 mL (1 mg/0.2 mL)] Rx onlyProduct nameAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC | Amneal Pharmaceuticals Private Limited2026-05-28
Leuprolide Acetate Injection Rx onlyProduct nameZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2026-05-25
Leuprolide Acetate Injection Rx OnlyProduct nameSandoz Inc2026-05-19
Leuprolide Acetate Injection Rx onlyProduct nameEugia US LLC | EUGIA Pharma Specialities Limited2026-05-08
These highlights do not include all the information needed to use ELIGARD ® safely and effectively. See full prescribing information for ELIGARD. ELIGARD (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 2002Product nameTOLMAR Inc.2026-04-30
These highlights do not include all the information needed to use VABRINTY™ safely and effectively. See full prescribing information for VABRINTY. VABRINTY (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 2002Product nameURONOVA PHARMACEUTICALS, INC.2026-04-30
Leuprolide Acetate Injection Rx onlyProduct nameSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2026-04-24
Leuprolide Acetate InjectionProduct nameMeitheal Pharmaceuticals Inc2026-04-23
Leuprolide Acetate Injection (leuprolide acetate) (For Subcutaneous Injection)Product nameAvenacy, LLC2026-04-13
Leuprolide Acetate Injection Rx onlyProduct nameZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2026-04-03
Leuprolide Acetate Injection (leuprolide acetate) Rx onlyProduct nameUBI Pharma Inc.2026-03-29
Leuprolide Acetate Injection Rx onlyProduct nameSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2026-03-27
These highlights do not include all the information needed to use LUPRON DEPOT safely and effectively. See full prescribing information for LUPRON DEPOT. LUPRON DEPOT ® (leuprolide acetate for depot suspension) Initial U.S. Approval: 1989Product nameAbbVie Inc.2026-03-15
Leuprolide Acetate Injection Rx onlyProduct nameEugia US LLC | EUGIA Pharma Specialities Limited2026-03-11
These highlights do not include all the information needed to use CAMCEVI ® safely and effectively. See full prescribing information for CAMCEVI. CAMCEVI (leuprolide) injectable emulsion, for subcutaneous use Initial U.S. Approval: 2021Product nameAccord BioPharma, Inc. | Fareva Pau | ScinoPharm Taiwan, Ltd.2026-02-18
These highlights do not include all the information needed to use CAMCEVI ® safely and effectively. See full prescribing information for CAMCEVI. CAMCEVI (leuprolide) injectable emulsion, for subcutaneous use Initial U.S. Approval: 2021Product nameAccord BioPharma, Inc. | Fareva Pau2026-02-18
Leuprolide Acetate Injection Rx onlyProduct nameZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2026-02-09
Leuprolide Acetate Injection Rx onlyProduct nameZydus Lifesciences Limited2026-02-09
These highlights do not include all the information needed to use CAMCEVI ® safely and effectively. See full prescribing information for CAMCEVI. CAMCEVI (leuprolide) injectable emulsion, for subcutaneous use Initial U.S. Approval: 2021Product nameAccord BioPharma, Inc. | Fareva Pau | ScinoPharm Taiwan, Ltd.2026-01-21
Leuprolide Acetate Injection (leuprolide acetate) Rx onlyProduct namePAI Holdings, LLC dba PAI Pharma2026-01-16
Leuprolide Acetate Injection (leuprolide acetate) Rx onlyProduct nameUBI Pharma Inc.2025-12-21
Leuprolide Acetate Injection [14 mg/2.8 mL (1 mg/0.2 mL)] Rx onlyProduct nameAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC | Amneal Pharmaceuticals Private Limited2025-12-17
Leuprolide Acetate Injection Rx onlyProduct nameVGYAAN Pharmaceuticals LLC | RK Pharma INC2025-11-21
These highlights do not include all the information needed to use LUPRON DEPOT-PED safely and effectively. See full prescribing information for LUPRON DEPOT-PED. LUPRON DEPOT-PED ® (leuprolide acetate for depot suspension) , for intramuscular use Initial U.S. Approval: 1985Product nameAbbVie Inc.2025-11-14
Leuprolide Acetate Injection Rx OnlyProduct nameSandoz Inc2025-11-03
Leuprolide Acetate Injection (leuprolide acetate) Rx onlyProduct nameUBI Pharma Inc.2025-10-06
These highlights do not include all the information needed to use FENSOLVI ® safely and effectively. See full prescribing information for FENSOLVI. FENSOLVI (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 1985Product nameTOLMAR Inc.2025-09-25
These highlights do not include all the information needed to use LUPRON DEPOT 3.75 mg safely and effectively. See full prescribing information for LUPRON DEPOT 3.75 mg. LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension) for injection, for intramuscular use Initial U.S. Approval: 1985Product nameAbbVie Inc.2025-09-18
These highlights do not include all the information needed to use LUPRON DEPOT 11.25 mg safely and effectively. See full prescribing information for LUPRON DEPOT 11.25 mg. LUPRON DEPOT 11.25 mg (leuprolide acetate for depot suspension) for injection, for intramuscular use Initial U.S. Approval: 1985Product nameAbbVie Inc.2025-09-10
These highlights do not include all the information needed to use LUPRON DEPOT safely and effectively. See full prescribing information for LUPRON DEPOT. LUPRON DEPOT (leuprolide acetate for depot suspension) Initial U.S. Approval: 1989Product nameAbbVie Inc.2025-08-18
Leuprolide Acetate Injection (leuprolide acetate) Rx onlyProduct nameUBI Pharma Inc.2025-06-30
Leuprolide Acetate Injection Rx onlyProduct nameNorthStar RxLLC | RK Pharma INC2025-06-24
Leuprolide Acetate InjectionProduct nameMeitheal Pharmaceuticals Inc2025-06-16
These highlights do not include all the information needed to use LUTRATE DEPOT safely and effectively. See full prescribing information for LUTRATE DEPOT. LUTRATE ® DEPOT (leuprolide acetate), for depot suspension Initial U.S. Approval: 2018Product nameAvyxa Pharma, LLC2025-06-03
These highlights do not include all the information needed to use VABRINTY™ safely and effectively. See full prescribing information for VABRINTY. VABRINTY (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 2002Product nameURONOVA PHARMACEUTICALS, INC.2025-06-01
These highlights do not include all the information needed to use VABRINTY™ safely and effectively. See full prescribing information for VABRINTY. VABRINTY (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 2002Product nameURONOVA PHARMACEUTICALS, INC.2025-06-01
These highlights do not include all the information needed to use VABRINTY™ safely and effectively. See full prescribing information for VABRINTY. VABRINTY (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 2002Product nameURONOVA PHARMACEUTICALS, INC.2025-06-01
Leuprolide Acetate Injection Rx onlyProduct nameSandoz Inc2024-11-26
These highlights do not include all the information needed to use LEUPROLIDE ACETATE FOR DEPOT SUSPENSION safely and effectively. See full prescribing information for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION. LEUPROLIDE ACETATE FOR DEPOT SUSPENSION. Initial U.S. Approval: 2018Product nameCIPLA USA INC. | GP PHARM SA2024-08-27
These highlights do not include all the information needed to use FENSOLVI ® safely and effectively. See full prescribing information for FENSOLVI. FENSOLVI (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 1985Product nameTOLMAR Inc.2022-04-28
These highlights do not include all the information needed to use CAMCEVI™ safely and effectively. See full prescribing information for CAMCEVI. CAMCEVI (leuprolide) injectable emulsion, for subcutaneous use Initial U.S. Approval: 2021Product nameForesee Pharmaceuticals Co., Ltd. | Pierre Fabre Medicament Production | ScinoPharm Taiwan, Ltd.2021-11-15
These highlights do not include all the information needed to use ELIGARD ® safely and effectively. See full prescribing information for ELIGARD ® . ELIGARD ® (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 2002Product nameTOLMAR Inc.2019-04-29
LUPRON ® INJECTION (leuprolide acetate)Product nameTAP Pharmaceutical Products Inc.2008-02-29
Viadur ® (leuprolide acetate implant)Product nameBayer Pharmaceuticals Corporation2006-05-10