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Details for New Drug Application (NDA): 018238

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NDA 018238 describes MICRO-K 10, which is a drug marketed by Nesher Pharms and is included in one NDA. It is available from seven suppliers. Additional details are available on the MICRO-K 10 profile page.

The generic ingredient in MICRO-K 10 is potassium chloride. There are two hundred and twenty-four drug master file entries for this compound. Seventy 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: 018238

Nesher Pharms
potassium chloride
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes

Pharmacology for NDA: 018238

Ingredient-typePotassium Compounds

Suppliers and Packaging for NDA: 018238

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
potassium chloride
CAPSULE, EXTENDED RELEASE;ORAL 018238 NDA AUTHORIZED GENERIC NCS HealthCare of KY, Inc dba Vangard Labs 0615-7646 0615-7646-05 15 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-7646-05)
potassium chloride
CAPSULE, EXTENDED RELEASE;ORAL 018238 NDA AUTHORIZED GENERIC NCS HealthCare of KY, Inc dba Vangard Labs 0615-7646 0615-7646-31 31 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-7646-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength8MEQ
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MEQ
Approval Date:May 14, 1984TE:ABRLD:No

Expired Orange Book Patents for NDA: 018238

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Nesher Pharms
potassium chloride
CAPSULE, EXTENDED RELEASE;ORAL018238-001Approved Prior to Jan 1, 19824,259,315<disabled>
Nesher Pharms
potassium chloride
CAPSULE, EXTENDED RELEASE;ORAL018238-002May 14, 19844,259,315<disabled>
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