Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 204326
Company: NEOS THERAPS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADZENYS XR-ODT AMPHETAMINE EQ 3.1MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription None Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 6.3MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription None Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 9.4MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription None Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 12.5MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription None Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 15.7MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription None Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 18.8MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription None Yes 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
01/27/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204326Orig1_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204326Orig1s002ltr.pdf
11/18/2016 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf
11/18/2016 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf
01/27/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English