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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209269

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NDA 209269 describes MINOLIRA, which is a drug marketed by Epi Hlth and is included in one NDA. It is available from one supplier. Additional details are available on the MINOLIRA profile page.

The generic ingredient in MINOLIRA is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 209269
Tradename:MINOLIRA
Applicant:Epi Hlth
Ingredient:minocycline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209269
Medical Subject Heading (MeSH) Categories for 209269
Suppliers and Packaging for NDA: 209269
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOLIRA minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 209269 NDA EPI Health, Inc 71403-101 71403-101-05 1 BOTTLE in 1 CARTON (71403-101-05) > 5 TABLET in 1 BOTTLE
MINOLIRA minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 209269 NDA EPI Health, Inc 71403-101 71403-101-30 1 BOTTLE in 1 CARTON (71403-101-30) > 30 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 105MG BASE
Approval Date:May 8, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 135MG BASE
Approval Date:May 8, 2017TE:RLD:No

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