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Generated: November 16, 2018

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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 four 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 thirty-eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.
Summary for 018238
Tradename:MICRO-K 10
Applicant:Nesher Pharms
Ingredient:potassium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018238
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MICRO-K 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)
MICRO-K 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)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength8MEQ
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MEQ
Approval Date:May 14, 1984TE:RLD:Yes

Expired US Patents for NDA 018238

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Nesher Pharms MICRO-K potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 018238-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Nesher Pharms MICRO-K 10 potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 018238-002 May 14, 1984 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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