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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, Miles, Hospira, Taro Pharms Ireland, Fresenius Kabi Usa, Haemonetics, Abbott, Medefil Inc, Jubilant Hollistrstr, Liebel-flarsheim, and Fresenius Medcl, and is included in twenty-five NDAs. It is available from fourteen 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 three hundred and fifty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

Summary for NDA: 078177

Tradename:
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:
Fresenius Medcl
Ingredient:
sodium chloride
Patents:0
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
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 North America 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

Summary for product number 001

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


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