U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209269
Company: EPI HLTH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOLIRA MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None No No
MINOLIRA MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/08/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209269Orig1s000TOC.cfm
Back to Top