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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 201850


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NDA 201850 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 Cadista, Laboratorios Grifols, Liebel-flarsheim, Miles, Nephron, and Taro, and is included in thirty-two NDAs. It is available from five 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 forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.
Summary for 201850
Tradename:SODIUM CHLORIDE 0.9%
Applicant:West-ward Pharms Int
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201850
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM CHLORIDE 0.9% sodium chloride INJECTABLE;INJECTION 201850 ANDA Hikma Pharmaceuticals USA Inc. 0641-1512 0641-1512-36 100 AMPULE in 1 CARTON (0641-1512-36) > 10 mL in 1 AMPULE (0641-1512-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength9MG/ML
Approval Date:Jan 20, 2012TE:APRLD:No

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