U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209410
Company: ADAMAS OPERATIONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OSMOLEX ER AMANTADINE HYDROCHLORIDE EQ 129MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OSMOLEX ER AMANTADINE HYDROCHLORIDE EQ 193MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OSMOLEX ER AMANTADINE HYDROCHLORIDE EQ 258MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
OSMOLEX ER AMANTADINE HYDROCHLORIDE EQ 161MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/16/2018 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209410s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209410Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209410Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/16/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209410s000lbl.pdf
Back to Top