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

Tradename:	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:	Sanofi Aventis Us
Ingredient:	milrinone lactate
Patents:	0

Medical Subject Heading (MeSH) Categories for 020343

Cardiotonic Agents
Phosphodiesterase 3 Inhibitors
Platelet Aggregation Inhibitors
Vasodilator Agents

Profile for product number 001

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INJECTABLE;INJECTION			Strength	EQ 10MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Profile for product number 002

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INJECTABLE;INJECTION			Strength	EQ 15MG BASE/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Profile for product number 003

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		Strength	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Expired US Patents for NDA 020343

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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	4,313,951*PED	⤷ Subscribe
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-003	Aug 9, 1994	4,313,951*PED	⤷ Subscribe
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-002	Aug 9, 1994	4,313,951*PED	⤷ Subscribe
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