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SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

NDA

SODIUM CHLORIDE | N021569 | LIEBEL-FLARSHEIM CO LLC

2 strengths0 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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs4 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

MARIAGER SALT SPECIALTIES A/SSODIUM CHLORIDE

DMF 221912010

NANDU CHEMICALS PVT LTDSODIUM CHLORIDE BP (PARENTERAL GRADE)

DMF 231052009

NANDU CHEMICALS PVT LTDSODIUM CHLORIDE USP

DMF 284732014

VM CHEMICALSSODIUM CHLORIDE BP

DMF 290372015

EMNAR PHARMA PRIVATE LTDSODIUM CHLORIDE

DMF 414192025

CAMBRIDGE NUCLEAR RADIOPHARM CORPInactiveSODIUM CHLORIDE NA-24

DMF 22861974

ARES SERONO SAInactiveSODIUM CHLORIDE FOR INJECTION

DMF 100301993

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM CHLORIDE INJECTION 0.9% 4ML FILL IN A 5ML VIAL

DMF 156592001

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM CHLORIDE INJECTION USP 0.9%

DMF 215442008

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jan 3, 2019	SUPPL -9	View Letter (PDF)
Mar 12, 2012	SUPPL -4	View Letter (PDF)
Apr 30, 2008	SUPPL -2	View Letter (PDF)
Aug 4, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 450MG/50ML (9MG/ML)

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 27, 2006

No patent or exclusivity listings for this strength.

#002 — 1.125GM/125ML (9MG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 27, 2006