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Generated: November 13, 2018

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 fourteen drug master file entries for this compound. Fifty-four 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
Ingredient-typeTetracyclines
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 Dr. Reddys Laboratories Inc 43598-539 43598-539-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-539-30)
MINOLIRA minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 209269 NDA Dr. Reddys Laboratories Inc 43598-540 43598-540-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-540-30)

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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