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Generated: November 21, 2018

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Details for New Drug Application (NDA): 206171

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NDA 206171 describes SODIUM CHLORIDE 0.9%, which is a drug marketed by B Braun, Medefil Inc, Spectra Mdcl Devices, West-ward Pharms Int, Baxter Hlthcare, Abbott, Fresenius Kabi Usa, Fresenius Medcl, Haemonetics, Hospira, Icu Medical Inc, Jubilant Hollistrstr, Laboratorios Grifols, Liebel-flarsheim, Miles, and Taro, and is included in thirty-one NDAs. It is available from four suppliers. Additional details are available on the SODIUM CHLORIDE 0.9% profile page.

The generic ingredient in SODIUM CHLORIDE 0.9% is potassium chloride; sodium chloride. There are two hundred and thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.
Summary for 206171
Tradename:SODIUM CHLORIDE 0.9%
Applicant:Spectra Mdcl Devices
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206171
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM CHLORIDE 0.9% sodium chloride INJECTABLE;INJECTION 206171 ANDA Spectra Medical Devices, Inc. 65282-1505 65282-1505-1 5 TRAY in 1 CARTON (65282-1505-1) > 5 AMPULE in 1 TRAY > 5 mL in 1 AMPULE
SODIUM CHLORIDE 0.9% sodium chloride INJECTABLE;INJECTION 206171 ANDA Spectra Medical Devices, Inc. 65282-1510 65282-1510-1 5 TRAY in 1 CARTON (65282-1510-1) > 5 AMPULE in 1 TRAY > 10 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength9MG/ML
Approval Date:Jul 21, 2017TE:APRLD:No

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