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Generated: November 15, 2018

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Details for New Drug Application (NDA): 201833

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NDA 201833 describes SODIUM CHLORIDE 0.9% , which is a drug marketed by West-ward Pharms Int, 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-nine 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 201833
Tradename:SODIUM CHLORIDE 0.9%
Applicant:West-ward Pharms Int
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201833
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM CHLORIDE 0.9% sodium chloride INJECTABLE;INJECTION 201833 ANDA West-Ward Pharmaceutical Corp. 0641-0497 0641-0497-25 25 VIAL in 1 CARTON (0641-0497-25) > 2 mL in 1 VIAL (0641-0497-17)
SODIUM CHLORIDE 0.9% sodium chloride INJECTABLE;INJECTION 201833 ANDA West-Ward Pharmaceutical Corp. 0641-6144 0641-6144-25 25 VIAL in 1 CARTON (0641-6144-25) > 10 mL in 1 VIAL (0641-6144-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength9MG/ML
Approval Date:Sep 24, 2013TE:RLD:No

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