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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 078177


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NDA 078177 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Abbott, Fresenius Kabi Usa, Fresenius Medcl, Haemonetics, Hospira, Icu Medical Inc, Jubilant Cadista, Laboratorios Grifols, Liebel-flarsheim, Medefil Inc, Miles, Nephron, and Taro, and is included in twenty-eight NDAs. It is available from eighteen suppliers. Additional details are available on the SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 078177
Tradename:SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Fresenius Medcl
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078177
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 078177 ANDA Fresenius Medical Care de Mexico, S.A. de C.V. 46163-300 46163-300-10 12 BAG in 1 CARTON (46163-300-10) > 1000 mL in 1 BAG
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 078177 ANDA Fresenius Medical Care North America 49230-300 49230-300-10 12 BAG in 1 CARTON (49230-300-10) > 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength900MG/100ML
Approval Date:Apr 12, 2007TE:APRLD:No

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