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Generated: January 19, 2019

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Details for New Drug Application (NDA): 207956

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NDA 207956 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 Hollistrstr, Laboratorios Grifols, Liebel-flarsheim, Medefil Inc, Miles, and Taro, and is included in twenty-seven 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-three suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 207956
Tradename:SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Laboratorios Grifols
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207956
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 207956 ANDA LABORATORIOS GRIFOLS SA 76297-001 76297-001-01 20 BAG in 1 CARTON (76297-001-01) > 500 mL in 1 BAG (76297-001-02)
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 207956 ANDA LABORATORIOS GRIFOLS SA 76297-001 76297-001-11 115 BAG in 1 CARTON (76297-001-11) > 50 mL in 1 BAG (76297-001-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength900MG/100ML
Approval Date:May 25, 2017TE:APRLD:No

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