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Last Updated: November 13, 2019

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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. Two 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 28, 2000TE:ABRLD:Yes

Expired US Patents for NDA 020687

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

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