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Details for New Drug Application (NDA): 203106

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NDA 203106 describes KLOR-CON, which is a drug marketed by Upsher-smith Labs and Upsher Smith Labs and is included in three NDAs. It is available from twenty-one suppliers. Additional details are available on the KLOR-CON profile page.

The generic ingredient in KLOR-CON is potassium chloride. There are two hundred and twenty-five drug master file entries for this compound. Seventy-one suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the potassium chloride profile page.

Summary for NDA: 203106

Tradename:
KLOR-CON
Applicant:
Upsher-smith Labs
Ingredient:
potassium chloride
Patents:0
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details

Pharmacology for NDA: 203106

Ingredient-typePotassium Compounds

Suppliers and Packaging for NDA: 203106

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KLOR-CON
potassium chloride
CAPSULE, EXTENDED RELEASE;ORAL 203106 ANDA Upsher-Smith Laboratories, Inc. 0245-0101 0245-0101-00 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0245-0101-00)
KLOR-CON
potassium chloride
CAPSULE, EXTENDED RELEASE;ORAL 203106 ANDA Upsher-Smith Laboratories, Inc. 0245-0101 0245-0101-01 10 BLISTER PACK in 1 CARTON (0245-0101-01) > 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0245-0101-89)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength8MEQ
Approval Date:Jul 10, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MEQ
Approval Date:Jul 10, 2015TE:ABRLD:No


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