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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 020687

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NDA 020687 describes MIFEPREX, which is a drug marketed by Danco Labs Llc and is included in one NDA. Additional details are available on the MIFEPREX profile page.

The generic ingredient in MIFEPREX is mifepristone. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mifepristone profile page.

Summary for 020687

Tradename:	MIFEPREX
Applicant:	Danco Labs Llc
Ingredient:	mifepristone
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 020687

Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 28, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020687

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000	⤷ Try a Trial	⤷ Try a Trial
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000	⤷ Try a Trial	⤷ Try a Trial
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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