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Generated: January 23, 2019

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Details for New Drug Application (NDA): 088912

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NDA 088912 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 088912
Tradename:SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Fresenius Kabi Usa
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 088912
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 088912 ANDA Cardinal Health 55154-9357 55154-9357-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9357-5) > 10 mL in 1 VIAL, SINGLE-DOSE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 088912 ANDA Fresenius Kabi USA, LLC 63323-186 63323-186-00 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-186-00) > 100 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength9MG/ML
Approval Date:Jan 10, 1985TE:APRLD:No

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