Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020343

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PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER (MILRINONE LACTATE)
EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: MILRINONE LACTATE
Proprietary Name: PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020343
Product Number: 001
Approval Date: Aug 9, 1994
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER (MILRINONE LACTATE)
EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: MILRINONE LACTATE
Proprietary Name: PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020343
Product Number: 002
Approval Date: Aug 9, 1994
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER (MILRINONE LACTATE)
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: MILRINONE LACTATE
Proprietary Name: PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020343
Product Number: 003
Approval Date: Aug 9, 1994
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER (MILRINONE LACTATE)
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: MILRINONE LACTATE
Proprietary Name: PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020343
Product Number: 004
Approval Date: Aug 9, 1994
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information