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Generated: September 23, 2017

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Details for New Drug Application (NDA): 019635

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NDA 019635 describes SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and B Braun and is included in two NDAs. It is available from two suppliers. Additional details are available on the SODIUM CHLORIDE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in SODIUM CHLORIDE 5% IN PLASTIC CONTAINER is sodium chloride. There are one thousand three hundred and ninety-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

Summary for NDA: 019635

Tradename:	5
Applicant:	1
Ingredient:	1
Patents:	0
Therapeutic Class:	Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019635

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 019635

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-7800	0264-7800-00	12 CONTAINER in 1 CASE (0264-7800-00) > 1000 mL in 1 CONTAINER
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-7800	0264-7800-10	24 CONTAINER in 1 CASE (0264-7800-10) > 500 mL in 1 CONTAINER

Summary for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	450MG/100ML
Approval Date:	Mar 9, 1988	TE:	AP	RLD:	Yes

Summary for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	900MG/100ML
Approval Date:	Mar 9, 1988	TE:	AP	RLD:	Yes

Summary for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3GM/100ML
Approval Date:	Mar 9, 1988	TE:	AP	RLD:	No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.