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SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER

NDA

SODIUM LACTATE | N018249 | HOSPIRA INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

500 trials from ClinicalTrials.gov, 21 active, 478 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients NCT01398085	Phase 2/3	Active	University College, London	504	2012-06-26 → 2031-03
Intravenous Estrogen in Kidney Transplant Study NCT03663543	Phase 1/2	Active	University of Pennsylvania	30	2016-08-26 → 2027-05-01
The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial NCT02261415	Phase 3	Active	Sunnybrook Health Sciences Centre	1,386	2014-11 → 2027-08
Angiotensin-(1-7) and Energy Expenditure in Human Obesity NCT03777215	Early Phase 1	Active	Amy Arnold	30	2019-09-26 → 2026-12
Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma NCT02112916	Phase 3	Active	National Cancer Institute (NCI)	847	2014-10-04 → 2026-09-16
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma NCT02068586	Phase 2	Active	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	210	2014-11-19 → 2026-12-31
Optical Tissue Identification for Myocardial Architecture NCT04017975	Phase 2	Active	Aditya Kaza	70	2019-12-20 → 2023-09
Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia NCT02143414	Phase 2	Active	National Cancer Institute (NCI)	53	2015-06-30 → 2027-01-26
VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer NCT03120624	Phase 1	Active	Mayo Clinic	34	2017-09-15 → 2028-01-01
Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps NCT02134925	Phase 2	Active	National Cancer Institute (NCI)	110	2014-06-23 → 2027-03-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

LUOYANG LONGMEN PHARMACEUTICAL CO LTDSODIUM LACTATE SOLUTION

DMF 352582020

MACCO ORGANIQUES SROSODIUM LACTATE SOLUTION 60%

DMF 417222025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 1.87GM/100ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.