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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077419

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NDA 077419 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-two 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 077419
Tradename:POTASSIUM CHLORIDE
Applicant:Actavis Labs Fl Inc
Ingredient:potassium chloride
Patents:0
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077419
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CHLORIDE potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 077419 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1318 0615-1318-39 30 CAPSULE in 1 BLISTER PACK (0615-1318-39)
POTASSIUM CHLORIDE potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 077419 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1318 0615-1318-05 15 CAPSULE in 1 BLISTER PACK (0615-1318-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength8MEQ
Approval Date:Jun 2, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MEQ
Approval Date:Jun 2, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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Cerilliant
Queensland Health
Farmers Insurance
US Department of Justice
Moodys
Merck
AstraZeneca
Healthtrust

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