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Details for New Drug Application (NDA): 208019

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NDA 208019 describes POTASSIUM CHLORIDE, which is a drug marketed by Lupin Ltd, Baxter Hlthcare, Abraxis Pharm, Actavis Labs Fl Inc, Hospira, Watson Labs, Kremers Urban Pharms, Lehigh Valley, Fresenius Kabi Usa, Copley Pharm, Pharma Res Software, Gd Searle Llc, Luitpold, Amneal Pharms, Novel Labs Inc, Sigmapharm Labs Llc, Teva, Schering, Tris Pharma Inc, Nesher Pharms, Pharmaceutics Intl, Pharma Serve Ny, Glenmark Pharms Ltd, Mylan Pharms Inc, Intl Medication, Lilly, Adare Pharms Inc, B Braun, Paddock Llc, Anchen Pharms, Akorn, Miles, and Icu Medcl, and is included in seventy-five NDAs. It is available from forty-eight 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 fifty-nine 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 NDA: 208019

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

Pharmacology for NDA: 208019

Ingredient-typePotassium Compounds

Suppliers and Packaging for NDA: 208019

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CHLORIDE
potassium chloride
FOR SOLUTION;ORAL 208019 NDA Qualitest Pharmaceuticals 0603-1554 0603-1554-04 100 POUCH in 1 CARTON (0603-1554-04) > 1.58 g in 1 POUCH (0603-1554-10)
POTASSIUM CHLORIDE
potassium chloride
FOR SOLUTION;ORAL 208019 NDA Qualitest Pharmaceuticals 0603-1554 0603-1554-16 30 POUCH in 1 CARTON (0603-1554-16) > 1.58 g in 1 POUCH (0603-1554-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength20MEQ
Approval Date:Aug 19, 2015TE:RLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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