Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205489
Company: NEOS THERAPS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COTEMPLA XR-ODT METHYLPHENIDATE 8.6MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription None Yes No
COTEMPLA XR-ODT METHYLPHENIDATE 17.3MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription None Yes No
COTEMPLA XR-ODT METHYLPHENIDATE 25.9MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription 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
06/19/2017 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205489Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205489Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/19/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf

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