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SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

NDA

SODIUM CHLORIDE | N019022 | BAXTER HEALTHCARE CORP

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

5 letters from Drugs@FDA

Date	Submission	Document
Sep 18, 2018	SUPPL -31	View Letter (PDF)
Dec 30, 2014	SUPPL -26	View Letter (PDF)
Aug 31, 2005	SUPPL -22	View Letter (PDF)
Jun 14, 2005	SUPPL -21	View Letter (PDF)
Apr 3, 2002	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 3GM/100ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 1, 1983

No patent or exclusivity listings for this strength.

#002 — 5GM/100ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Nov 1, 1983