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Last Updated: November 15, 2024

Details for New Drug Application (NDA): 020343


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NDA 020343 describes PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER is milrinone lactate. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the milrinone lactate profile page.
Summary for 020343

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 9, 1994TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 9, 1994TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 9, 1994TE:RLD:Yes

Expired US Patents for NDA 020343

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 020343-001 Aug 9, 1994 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 020343-003 Aug 9, 1994 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 020343-002 Aug 9, 1994 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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