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SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER

NDA

SODIUM LACTATE | N016692 | BAXTER HEALTHCARE CORP

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease NCT06189963	Phase 1/2	Recruiting	NKGen Biotech, Inc.	36	2023-11-21 → 2027-06

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 24, 2011	SUPPL -95	View Letter (PDF)

Source: Drugs@FDA application documents.

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.