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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080205

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NDA 080205 describes POTASSIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Anchen Pharms, Glenmark Pharms Ltd, Kremers Urban Pharms, Lupin Ltd, Nesher Pharms, Novel Labs Inc, Paddock Llc, PII, Teva, Tris Pharma Inc, Pharma Res Software, Abraxis Pharm, Akorn, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Pharma Serve Ny, Watson Labs, Genus Lifesciences, Copley Pharm, Mylan Pharms Inc, Schering, Sigmapharm Labs Llc, and Icu Medical Inc, and is included in seventy-six NDAs. It is available from forty-nine suppliers. Additional details are available on the POTASSIUM CHLORIDE profile page.

The generic ingredient in POTASSIUM CHLORIDE is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and seventy drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.

Summary for 080205

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 080205

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CHLORIDE potassium chloride INJECTABLE;INJECTION 080205 ANDA Hospira, Inc. 0409-6635 0409-6635-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6635-01) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-6635-18)
POTASSIUM CHLORIDE potassium chloride INJECTABLE;INJECTION 080205 ANDA Hospira, Inc. 0409-6651 0409-6651-06 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6651-06) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-6651-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MEQ/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MEQ/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2.4MEQ/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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